Fistula flow disruptor methods

ABSTRACT

A method of disrupting flow through a fistula may include deploying a flow disruptor across the fistula through a microcatheter at a point in vasculature proximate to the fistula. Deploying the flow disruptor may include expanding a first bulb on a first side of the fistula and expanding a second bulb on a second side of the fistula, the flow disruptor including a neck between the first bulb and the second bulb and traversing the fistula. The first bulb may have a first braid angle, the second bulb may have a second braid angle, and the neck may have a third braid angle less than the first braid angle and the second braid angle.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 13/953,540, filed on Jul. 29, 2013.

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication, as well as U.S. patent application Ser. No. 13/952,982,filed on Jul. 29, 2013, and U.S. Provisional Patent App. No. 61/798,540,filed on Mar. 15, 2013, are hereby incorporated by reference under 37C.F.R. §1.57.

BACKGROUND

1. Field

The present disclosure generally relates to devices, systems, methodsfor making, and methods for use in vascular procedures such asthrombectomy and/or flow diversion. Several embodiments relate tothrombectomy systems and methods for providing approaches for thetreatment of stroke, peripheral vascular disease, coronary arterydisease, saphenous vein graft disease, clogged hemodialysis grafts,cerebral venous sinus thrombosis, and deep venous thrombosis. Severalembodiments relate to flow diversion and flow disruption systems andmethods for providing approaches for the treatment of brain arterialaneurysms, aortic aneurysms, cardiac wall aneurysms, atrial septaldefects and aneurysms including patent foramen ovale, ventricular septaldefects and aneurysms, coronary arterial aneurysms, peripheral arterialaneurysms, renal arterial aneurysms, and vascular malformationsincluding arterio-venous malformations and arterio-venous fistulae ofthe brain, spine, coronary and peripheral vasculature.

2. Description of the Related Art

Stroke is the leading cause of long term disability in the United Statesand the second leading cause of death worldwide with over 4.4 milliondeaths in a year (1999). There are over 795,000 new strokes every yearin the United States. Around 85% of all strokes are acute ischemicstrokes caused from a blockage in a blood vessel or a blood clotoccluding a blood vessel. In 1996, the FDA approved a thrombolytic drugto dissolve blood clots called recombinant tissue plasminogen activator(r-tpa). Despite practice guidelines from multiple nationalorganizations stating that intravenous r-tpa is the standard of care forpatients with acute ischemic stroke within 3 hours from symptom onset,only 3-4% of patients with acute ischemic stroke received this drug inthe United States. Unlike intravenous r-tpa, catheter-based therapiesfor mechanical thrombectomy can be used for up to 8 hours or beyond fromacute ischemic stroke symptom onset and could benefit more people. Withadvances in regional stroke networks, an increasing number of strokepatients are able to obtain access to intra-arterial thrombolysis andtherapies.

SUMMARY

Certain embodiments described herein disclose devices and methods forremoving a thrombus or thrombi. These thrombi include, but are notlimited to, blood clots (e.g., attached to the blood vessel) and emboli(e.g., floating blood clots), as well as other debris. Severalembodiments provide devices comprising multiple bulbs. Vessels or othertissues in the body can become partially or fully clogged or blocked bya thrombus or thrombi. Although some clot retrievers or thrombectomydevices that employ a laser cut hypotube on a distal end of a wire arecommercially available, some embodiments disclosed herein do not uselaser cut struts and are gentle on the vessel wall, while effectivelyand efficiently capturing a thrombus in any location in the body. Somedevices can be torsional rasped (e.g., wrung or twisted) to help capturethrombi. Certain embodiments described herein disclose devices andmethods for treating aneurysms, vascular malformations, fistulas, andthe like.

Several embodiments of the devices and methods described herein may beparticularly beneficial by achieving one, some, or all of the followingadvantages:

adapted for, and gentle on, the fragile blood vessels in contrast to anexpansile laser-cut stent-based mechanical thrombectomy device;

tapered to at least partially mimic the tapering of the human bloodvessels, which can allow for the use of a single tapered device toremove blood clots extending across different tapering blood vesseldiameters;

flexible during deployment and retrieval in tortuous human bloodvessels, which can allow for longer usable lengths of the device;

comprises a usable length customizable to the length of a thrombus orclot burden without having to use multiple devices to remove thethrombus piecemeal;

a textile structure-based mechanical thrombectomy device that can allowfor torsional rasping of the textile structure around a thrombus toentrap and retrieve the thrombus;

patterns of radiopaque filaments or wires that increase visibility underX-ray fluoroscopy;

allows for longitudinal crowding of filaments that varies pore sizes ofcertain sections during operation for selective filtering intobifurcated vessels;

patterns of radiopaque filaments or wires provide measurement estimatesunder X-ray fluoroscopy;

provides filtering of distal emboli or debris that may be released;employs processes to couple a textile structure to a hypotube by bondingof different metals or alloys;

has a low overall profile in which the outer diameter of the mechanicalthrombectomy device in the collapsed configuration is less than, e.g.,about 0.0125 inches (approx. 0.317 mm);

has a low overall profile in which the mechanical thrombectomy device inthe collapsed configuration can be deployed using a microcatheter thathas an inner lumen diameter of less than, e.g., about 0.014 inch(approx. 0.355 mm);

varying slit patterns along the length of a hypotube, which can providedistal flexibility and proximal support;

varying shape set properties along the length of a hypotube, which canprovide distal flexibility and proximal support;

a hypotube that can support the ability to perform torsional rasping ofa thrombus;

a laser-cut hypotube with multiple transition points incorporated as thecore braid for the wall of the microcatheter, which can allow for distalflexibility and proximal support for allowing the safe and effectivedeployment of the textile structure based mechanical thrombectomydevice;

can be used without a separate embolic protection member (e.g., distalembolic protection member) to capture emboli;

can be used without reversal of blood flow, or otherwise impeding bloodflow, to protect against release of distal emboli; and/or

can be used without a balloon or other inflation device.

In some embodiments, a method of treating a thrombus in a vessel withself-expanding bulbs comprises advancing a guidewire in the vesselproximal to the thrombus, advancing a guide catheter in the vessel andover the guidewire, after advancing the guide catheter, removing theguidewire from the vessel, and advancing a microwire in the vessel andthrough the guide catheter. Advancing the microwire includes crossingthe thrombus (e.g., crossing the distal-most portion of the thrombus by0.5 mm to 5 mm). The method further comprises advancing a microcatheterin the vessel and over the microwire. Advancing the microcatheterincludes crossing the thrombus with a distal end of the microcatheter.The method further comprises, after advancing the microcatheter,removing the microwire from the vessel, and, after removing themicrowire, inserting a thrombectomy device from an introducer sheathinto the microcatheter. The thrombectomy device includes an elongatesupport structure and a delivery system coupled to the elongate supportstructure. The elongate support structure includes a plurality of wireswoven to form a textile fabric. The elongate support structure maycomprise or consist essentially of at least three (e.g., at least four,at least six, at least ten, etc.) self-expanding bulbs, a plurality ofnecks (e.g., longitudinally between and radially inward of theself-expanding bulbs), and a distal neck (e.g., radially inward of adistal-most bulb of the self-expanding bulbs). The delivery systemincludes a hypotube including a plurality of longitudinally-spaced kerfsincluding a plurality of interspersed cut patterns. A pitch of theplurality of longitudinally-spaced kerfs varies longitudinally along thehypotube. Each of the plurality of longitudinally-spaced kerfs includesrounded edges. The method further comprises, after inserting thethrombectomy device from the introducer sheath into the microcatheter,advancing the thrombectomy device in the vessel and through themicrocatheter proximate to the distal end of the microcatheter.Advancing the thrombectomy device includes crossing the thrombus withthe distal-most bulb of the self-expanding bulbs. The method furthercomprises, after advancing the thrombectomy device, maintaining alocation of the delivery system of the thrombectomy device whileretracting the microcatheter. Upon being unsheathed from themicrocatheter, at least some of the self-expanding bulbs of the elongatesupport structure of the thrombectomy device self-expand from a radiallycompressed state to a radially expanded state. The microcatheter, inseveral embodiments, is retracted at least until the distal end of themicrocatheter is proximal to the thrombus. The method further comprisesretracting the microcatheter and the delivery system of the thrombectomydevice into the guide catheter. During retraction of the microcatheterand the delivery system of the thrombectomy device, the some of theself-expanding bulbs remain in the radially expanded state, while othersof the self-expanding bulbs of the elongate support structure of thethrombectomy device in the radially contracted state remain in theradially contracted state. In some embodiments, all the bulbs arepartially or fully expanded during retraction. In other embodiments, allthe bulbs are partially or fully contracted during retraction.

The method may further comprise, before retracting the microcatheter andthe delivery system of the thrombectomy device into the guide catheter,torsionally rasping the thrombectomy device to, for example, removeportions of the thrombus attached to an endothelium wall, entrap thethrombus in the radially expanded elongate support structure of thethrombectomy device, and/or collect emboli in the radially expandedelongate support structure. Retracting the microcatheter and thedelivery system may be performed at a similar rate and while optionallyapplying negative pressure to the vessel. The vessel may comprise ablood vessel in a brain, leg, or other vessel or structure in the body.

In some embodiments, a method of treating a thrombus in a vessel withself-expanding bulbs comprises advancing a thrombectomy device through amicrocatheter in the vessel and across the thrombus. The thrombectomydevice includes an elongate support structure including more than twoself-expanding bulbs and a delivery system coupled to the elongatesupport structure. The delivery system includes a hypotube including aplurality of longitudinally-spaced kerfs. The method further comprisesretracting the microcatheter and expanding at least a portion of theelongate support structure of the thrombectomy device from a radiallycompressed state to a radially expanded state, torsionally rasping thethrombectomy device including entrapping the thrombus in the portion ofthe elongate support structure, and retracting the microcatheter and thedelivery system of the thrombectomy device into a guide catheter in thevessel. Although the bulbs are self-expanding in several embodiments,bulbs that expand upon exertion of force (e.g., mechanical force) can besubstituted in various embodiments described herein.

The elongate support structure may comprise at least two of the two ormore bulbs having different outer diameters in the radially expandedstate. The elongate support structure may be tapered. The plurality oflongitudinally spaced kerfs of the hypotube may include a plurality ofinterspersed cut patterns. A pitch of the plurality of longitudinallyspaced kerfs of the hypotube may vary longitudinally along the hypotube.The thrombectomy device in the radially compressed state may have athickness less than 0.0125 inches. Torsionally rasping the thrombectomydevice may include removing portions of the thrombus attached to anendothelium wall. Torsionally rasping the thrombectomy device mayinclude collecting one or more emboli released from the thrombus in theportion of the elongate support structure. Expanding the portion of theelongate support structure from the radially compressed state to theradially expanded state may comprise expanding the vessel by 0% to 30%.During torsionally rasping the thrombectomy device, a ratio of rotationof the delivery system of the thrombectomy device to rotation of theelongate support structure of the thrombectomy device may be between1:0.5 and 1:0.25. Torsionally rasping the thrombectomy device maycomprise rotating the delivery system of the thrombectomy device atleast 360 degrees, resulting in a rotation of the elongate supportstructure of the thrombectomy device of less than 360 degrees. Thevessel may comprise a blood vessel in a brain, leg, or other vessel orstructure in the body.

In some embodiments, a method of treating a thrombus in a vessel withself-expanding bulbs comprises advancing a thrombectomy device through amicrocatheter in the vessel. The thrombectomy device includes aplurality of self-expanding bulbs and a hypotube coupled to theself-expanding bulbs. The method further comprises retracting themicrocatheter to expand from a radially compressed state to a radiallyexpanded state at least some of the plurality of self-expanding bulbs,entrapping the thrombus in at least some of the plurality ofself-expanding bulbs in the radially expanded state, and retracting themicrocatheter and the thrombectomy device.

The hypotube may include a plurality of longitudinally-spaced kerfs. Themethod may further comprise torsionally rasping the thrombectomy device.Torsionally rasping the thrombectomy device may include entrapping thethrombus in the at least some of the plurality of self-expanding bulbsin the radially expanded state. The vessel may comprise a blood vesselin a brain, leg, or other vessel or structure in the body.

In some embodiments, a thrombectomy device comprises, or consistsessentially of, an elongate support structure, a delivery system, and abonding zone where the delivery system is coupled to the elongatesupport structure. The elongate support structure includes a pluralityof shape-memory and radiopaque wires woven to form a textile fabrichaving a collapsed state and an expanded state. The elongate supportstructure includes, or consists essentially of, a plurality ofself-expanding generally spherical bulbs in the expanded state, neckslongitudinally between and radially inward of the self-expanding bulbs,and a distal neck distal to and radially inward of a distal-most bulb ofthe self-expanding bulbs. In one embodiment, the plurality of bulbsconsists essentially of five to fifteen bulbs that have rounded orcurved portions. In several embodiments, the plurality of self-expandinggenerally spherical bulbs includes a first bulb, a second bulb distal tothe first bulb, a third bulb distal to the second bulb, a fourth bulbdistal to the third bulb, a fifth bulb distal to the fourth bulb, asixth bulb distal to the fifth bulb, a seventh bulb distal to the sixthbulb, an eighth bulb distal to the seventh bulb, a ninth bulb distal tothe eighth bulb, and a tenth bulb distal to the ninth bulb. The firstbulb and the second bulb have a first diameter. The third bulb and thefourth bulb have a second diameter smaller than the first diameter. Thefifth bulb, the sixth bulb, and the seventh bulb have a third diametersmaller than the second diameter. The eighth bulb, the ninth bulb, andthe tenth bulb have a fourth diameter smaller than the third diameter.The distal neck includes a coated distal end in several embodiments. Thedelivery system may include a hypotube including two longitudinallyinterspersed and circumferentially staggered cut patterns. The cutpatterns may each include a plurality of rows each including twolongitudinally-spaced kerfs angled with respect to a longitudinal axisof the hypotube and including rounded edges. A longitudinally-spacing ofthe kerfs may vary along the hypotube. The bonding zone includes aradiopaque marker band in some embodiments.

An outer diameter of the elongate support structure in the collapsedstate may be less than about 0.0125 inches. An outer diameter of theelongate support structure in the collapsed state may be in a range ofabout 0.1-0.9 mm (e.g., about 0.25 mm to about 0.5 mm). The firstdiameter may be about 4.5 mm. The second diameter may be about 4 mm. Thethird diameter may be about 3.5 mm. The fourth diameter may be about 3mm.

In some embodiments, a thrombectomy device comprises an elongate supportstructure and a delivery system. The elongate support structure includesa plurality of wires woven to form a textile fabric having a collapsedstate and an expanded state. The elongate support structure includes aplurality of longitudinally-spaced self-expanding bulbs in the expandedstate. The delivery system includes a hypotube including a plurality oflongitudinally interspersed cut patterns each including a plurality ofrows of longitudinally-spaced kerfs.

The plurality of bulbs may comprise or consist essentially of ten ormore bulbs. At least two of the plurality of bulbs may have differentouter diameters in the expanded state. At least two of the plurality ofbulbs may have different shapes in the expanded state. At least one ofthe plurality of bulbs may have a spherical shape in the expanded state.At least one of the plurality of bulbs may have a oblong shape in theexpanded state. Longitudinal spacing between the plurality of bulbs maybe constant. The plurality of wires may include shape memory andradiopaque wires. The radiopaque wires may be clustered to enhancevisibility under x-ray. An outer diameter of the elongate supportstructure in the collapsed state may be less than about 0.0125 inches.Each of the rows may be angled with respect to a longitudinal axis ofthe hypotube. The kerfs may include rounded edges. Although ten or morebulbs (e.g., 15, 20, 25, 30, or more bulbs) are provided in someembodiments, fewer than ten bulbs are provided in other embodiments (forexample, for shorter targeted segments).

In some embodiments, a device for treating a thrombus in a vesselcomprises or consists essentially of an elongate support structureincluding a plurality of wires woven to form a textile structureincluding a plurality of bulbs in a radially expanded state, a deliverysystem including a hypotube including at least two interspersed patternsof longitudinally-spaced rows of kerfs, and a bonding zone where thedelivery system may be coupled to the elongate support structure. Thebonding zone includes a radiopaque marker band in some embodiments.

The bonding zone may include a proximal end of the elongate supportstructure within a distal end of the delivery system. The bonding zonemay include a proximal end of the elongate support structure over adistal end of the delivery system. The bonding zone may include a distalend of the elongate support structure over a distal end of the deliverysystem.

In some embodiments, a method of treating a thrombus in a vessel withself-expanding bulbs comprises advancing a microwire in the vessel andthrough a guide catheter. Advancing the microwire includes crossing thethrombus with a distal end of the microwire. The method furthercomprises advancing a microcatheter in the vessel and over themicrowire. Advancing the microcatheter includes crossing the thrombuswith a distal end of the microcatheter. The method further comprises,after advancing the microcatheter, removing the microwire from thevessel, and, after removing the microwire, inserting a thrombectomydevice in a radially compressed state into the microcatheter. Thethrombectomy device includes a distal portion and a proximal portionbonded to the distal portion. The distal portion includes a plurality ofwires woven to form a textile fabric. The distal portion comprises atleast three (e.g., at least four, at least six, at least ten, etc.)self-expanding bulbs and necks between and radially inward of theself-expanding bulbs. The proximal portion includes a hypotube includinga plurality of longitudinally-spaced kerfs including a plurality ofinterspersed cut patterns. A pitch of the plurality oflongitudinally-spaced kerfs varies longitudinally along the hypotube.The method further comprises, after inserting the thrombectomy deviceinto the microcatheter, advancing the thrombectomy device in the vesseland through the microcatheter proximate to the distal end of themicrocatheter. Advancing the thrombectomy device includes crossing thethrombus with the distal-most bulb of the self-expanding bulbs. Themethod further comprises, after advancing the thrombectomy device,maintaining a location of the proximal portion of the thrombectomydevice while proximally retracting the microcatheter. Upon beingunsheathed from the microcatheter, at least some of the self-expandingbulbs of the elongate support structure of the thrombectomy deviceself-expand from a radially compressed state to a radially expandedstate. Retracting the microcatheter is at least until the distal end ofthe microcatheter is proximal to the thrombus. The method furthercomprises, after retracting the microcatheter, torsionally rasping thethrombectomy device including removing portions of the thrombus attachedto an endothelium wall, entrapping the thrombus in the radially expandeddistal portion of the thrombectomy device, and collecting emboli in theradially expanded distal portion of the thrombectomy device. The methodfurther comprises, after torsionally rasping the thrombectomy device,retracting at a similar rate the microcatheter and the proximal portionof the thrombectomy device. The vessel may comprise a blood vessel in abrain, leg, or other vessel or structure in the body.

In some embodiments, a method of treating a thrombus in a vessel withself-expanding bulbs comprises expanding from a radially compressedstate to a radially expanded state a plurality of self-expanding bulbsof a distal portion of a thrombectomy device, entrapping the thrombus inat least some of the plurality of self-expanding bulbs in the radiallyexpanded state, and retracting the thrombectomy device from the vessel.

The distal portion of the thrombectomy device comprises at least two ofthe plurality of bulbs may have different outer diameters in theradially expanded state. The distal portion of the thrombectomy devicemay be tapered. The distal portion of the thrombectomy device maycomprise at least two of the plurality of self-expanding bulbs havingdifferent shapes in the radially expanded state. The distal portion ofthe thrombectomy device may comprise at least two of the plurality ofself-expanding bulbs separated by a neck. The thrombectomy device maycomprise a proximal portion coupled to the distal portion. The proximalportion may include a hypotube including a plurality of longitudinallyspaced kerfs. The plurality of longitudinally spaced kerfs may include aplurality of interspersed cut patterns. A pitch of the plurality oflongitudinally spaced kerfs may vary longitudinally along the hypotube.At least some of the plurality of longitudinally spaced kerfs mayinclude rounded edges. Expanding the plurality of self-expanding bulbsmay include proximally retracting a microcatheter surrounding theplurality of self-expanding bulbs in the radially compressed state.Retracting the microcatheter may be at least until a distal end of themicrocatheter is proximal to the thrombus. Retracting the thrombectomydevice from the vessel comprises retracting the microcatheter may be ata similar rate. Entrapping the thrombus may include torsionally raspingthe thrombectomy device. The vessel may comprise a blood vessel in abrain, leg, or other vessel or structure in the body.

In some embodiments, a method of treating a thrombus in a vessel withself-expanding bulbs comprises torsionally rasping a distal portion of athrombectomy device. The distal portion includes a plurality ofself-expanding bulbs. Torsionally rasping may effect at least one of:removing portions of the thrombus attached to an endothelium wall of thevessel, entrapping the thrombus in the distal portion of thethrombectomy device, and collecting emboli in the distal portion of thethrombectomy device.

Torsionally rasping the distal portion of the thrombectomy device maycomprise rotating a proximal portion of the thrombectomy device coupledto the distal portion of the thrombectomy device. The proximal portionmay include a hypotube including a plurality of longitudinally-spacedkerfs. The vessel may comprise a blood vessel in a brain, leg, or othervessel or structure in the body.

In some embodiments, a device for treating a thrombus in a vesselcomprises a distal portion and a proximal portion coupled to a proximalend of the distal portion. The distal portion includes a plurality ofwires woven to form a textile structure. The plurality of wires includesradiopaque wires and shape-memory wires. The distal portion includes atleast ten self-expanding bulbs, at least nine necks longitudinallybetween the ten self-expanding bulbs and radially inward of the tenself-expanding bulbs, and a distal neck distal to the distal-most of theat least ten self-expanding bulbs. The proximal portion includes ahypotube having a longitudinal axis. The proximal portion comprises afirst pattern of longitudinally-spaced rows each including two kerfs andtwo stems and a second pattern of longitudinally-spaced rows eachincluding two kerfs and two stems. The rows of the first pattern are atan angle with respect to the longitudinal axis of the hypotube. The twokerfs in each of the rows of the first pattern have rounded edges. Thetwo stems in each of the rows of the first pattern are circumferentially180° apart. The stems of the first pattern are offset in a firstcircumferential direction. A pitch of the longitudinally-spaced rows ofthe first pattern varies longitudinally along the hypotube. The rows ofthe second pattern is at an angle with respect to the longitudinal axisof the hypotube. The two kerfs in each of the rows of the second patternhave rounded edges. The two stems in each of the rows of the secondpattern are circumferentially 180° apart. The rows of the second patternare singly alternatingly interspersed with the rows of the firstpattern. The stems of the second pattern offset in a secondcircumferential direction opposite the first circumferential direction.A pitch of the longitudinally-spaced kerfs of the second pattern varieslongitudinally along the hypotube.

The at least ten self-expanding bulbs may comprise a first bulb, asecond bulb distal to the first bulb, a third bulb distal to the secondbulb, a fourth bulb distal to the third bulb, a fifth bulb distal to thefourth bulb, a sixth bulb distal to the fifth bulb, a seventh bulbdistal to the sixth bulb, an eighth bulb distal to the seventh bulb, aninth bulb distal to the eighth bulb, and a tenth bulb distal to theninth bulb. The first bulb and the second bulb may have a firstdiameter. The third bulb and the fourth bulb may have a second diametersmaller than the first diameter. The fifth bulb, the sixth bulb, and theseventh bulb may have a third diameter smaller than the second diameter.The eighth bulb, the ninth bulb, and the tenth bulb may have a fourthdiameter smaller than the third diameter. The second bulb may have agenerally spherical shape. The third bulb may have a generally oblongshape. The fourth bulb may have a generally spherical shape. The fifthbulb may have a generally oblong shape. The sixth bulb may have agenerally spherical shape. The seventh bulb may have a generallyspherical shape. The eighth bulb may have a generally oblong shape. Theninth bulb may have a generally spherical shape. The tenth bulb may havea generally spherical shape.

In some embodiments, a device for treating a thrombus in a vesselcomprises a first portion and a second portion bonded to the firstportion. The first portion includes a plurality of wires woven to form atextile structure. The plurality of wires includes radiopaque wires andshape-memory wires, the textile structure includes a plurality of bulbsspaced by a plurality of necks in a radially expanded state. The secondportion includes a hypotube having a longitudinal axis. The hypotubeincludes at least two interspersed patterns of longitudinally-spacedrows of kerfs. A pitch of the longitudinally-spaced rows of kerfs variesalong the longitudinal axis of the hypotube.

The plurality of bulbs may include ten or more bulbs. Fewer bulbs areincluded in some embodiments. At least two of the plurality of bulbs mayhave different outer diameters in the radially expanded state. At leasttwo of the plurality of bulbs may have different shapes in the radiallyexpanded state. At least one of the plurality of bulbs may have aspherical shape in the radially expanded state. At least one of theplurality of bulbs may have an oblong shape in the radially expandedstate. The radiopaque wires are spaced or clustered to increasevisibility under x-ray. Each of the rows may be angled with respect tothe longitudinal axis of the hypotube. Each of the rows may include twokerfs and two stems. The stems in each of the rows may becircumferentially 180° apart. The at least two interspersed patterns mayinclude a first pattern including the stems circumferentially offset ina first direction and a second pattern including the stemscircumferentially offset in a second direction opposite the firstdirection.

In some embodiments, a device for treating a thrombus in a vesselcomprises a first portion including a plurality of wires woven to form atextile structure including a plurality of bulbs in a radially expandedstate, a second portion including a hypotube including at least twointerspersed patterns of longitudinally-spaced rows of kerfs, and ajoint coupling the first portion and the second portion.

The joint may include lead-free solder. The joint may include a proximalend of the first portion within a distal end of the second portion. Thejoint may include a proximal end of the first portion over a distal endof the second portion. The joint may include a distal end of the firstportion over a distal end of the second portion.

In some embodiments, a device for treating a thrombus in a vesselcomprises a plurality of wires woven to form a textile fabric. Thetextile fabric includes ten self-expanding bulbs, nine neckslongitudinally between the ten self-expanding bulbs, and a distal neckdistal to the distal-most of the ten self-expanding bulbs. The pluralityof wires includes a plurality of radiopaque wires and a plurality ofshape-memory wires.

The ten self-expanding bulbs may comprise a first bulb, a second bulbdistal to the first bulb, a third bulb distal to the second bulb, afourth bulb distal to the third bulb, a fifth bulb distal to the fourthbulb, a sixth bulb distal to the fifth bulb, a seventh bulb distal tothe sixth bulb, an eighth bulb distal to the seventh bulb, a ninth bulbdistal to the eighth bulb, and a tenth bulb distal to the ninth bulb.The first bulb and the second bulb may have a first diameter. The thirdbulb and the fourth bulb may have a second diameter smaller than thefirst diameter. The fifth bulb, the sixth bulb, and the seventh bulb mayhave a third diameter smaller than the second diameter. The eighth bulb,the ninth bulb, and the tenth bulb may have a fourth diameter smallerthan the third diameter. The first bulb may have a generally oblongshape. The second bulb may have a generally spherical shape. The thirdbulb may have a generally oblong shape. The fourth bulb may have agenerally spherical shape. The fifth bulb may have a generally oblongshape. The sixth bulb may have a generally spherical shape. The seventhbulb may have a generally spherical shape. The eighth bulb may have agenerally oblong shape. The ninth bulb may have a generally sphericalshape. The tenth bulb may have a generally spherical shape. The firstbulb and the second bulb may have a first diameter. The third bulb andthe fourth bulb may have a second diameter smaller than the firstdiameter. The fifth bulb, the sixth bulb, and the seventh bulb may havea third diameter smaller than the second diameter. The eighth bulb, theninth bulb, and the tenth bulb may have a fourth diameter smaller thanthe third diameter.

In some embodiments, a device for treating a thrombus in a vesselcomprises a plurality of wires woven to form a textile fabric includinga plurality of bulbs spaced by a plurality of necks in a radiallyexpanded state. The plurality of wires includes shape-memory wires andclustered radiopaque wires.

The radiopaque wires may include platinum tungsten. The shape memorywires may include nickel titanium. The plurality of bulbs may includeten bulbs. At least two of the plurality of bulbs may have differentouter diameters in the radially expanded state. A diameter of the devicein a collapsed state may be no more than about 0.0125 inches (approx.0.317 mm). At least two of the plurality of bulbs may have differentshapes in the radially expanded state. At least one of the plurality ofbulbs may have a spherical shape in the radially expanded state. Atleast one of the plurality of bulbs may have an oblong shape in theradially expanded state.

In some embodiments, a device for treating a thrombus in a vesselcomprises a plurality of wires woven to form a textile fabric includinga radially collapsed state having a diameter between about 0.1 mm andabout 0.9 mm (e.g., between about 0.25 mm and about 0.5 mm) and aradially expanded state having a diameter between about 1 mm and about30 mm (e.g., between about 1 mm and about 6.5 mm, between about 3 mm andabout 4.5 mm). In some embodiments, the radially contracted state isabout 10 to about 30 times smaller in at least one dimension than theradially expanded state. The textile fabric includes a plurality ofbulbs in the radially expanded state.

The plurality of bulbs may include ten bulbs. At least two of theplurality of bulbs may have different outer diameters in the radiallyexpanded state. At least two of the plurality of bulbs may havedifferent shapes in the radially expanded state. At least one of theplurality of bulbs may have a spherical shape in the radially expandedstate. At least one of the plurality of bulbs may have an oblong shapein the radially expanded state. The plurality of bulbs may be spaced bynecks.

In some embodiments, a device for treating a thrombus in a vesselcomprises a hypotube having a longitudinal axis. The hypotube includes afirst pattern of longitudinally-spaced rows each including two kerfs andtwo stems and a second pattern of longitudinally-spaced rows eachincluding two kerfs and two stems. The rows of the first pattern are atan angle with respect to the longitudinal axis of the hypotube. The twokerfs in each of the rows of the first pattern have rounded edges. Thetwo stems in each of the rows of the first pattern are circumferentiallyabout 180° apart. The stems of the first pattern are offset in a firstcircumferential direction. The rows of the second pattern are at anangle with respect to the longitudinal axis of the hypotube. The twokerfs in each of the rows of the second pattern have rounded edges. Thetwo stems in each of the rows of the second pattern arecircumferentially about 180° apart. The rows of the second pattern aresingly alternatingly interspersed with the rows of the first pattern.The stems of the second pattern are offset in a second circumferentialdirection opposite the first circumferential direction. A pitch of thelongitudinally-spaced kerfs of first pattern and the second patternvaries longitudinally along the hypotube.

The hypotube may include a first section, a second section, a thirdsection, a fourth section, a fifth section, and a sixth section. Thefirst section may have a pitch of about 0.005 inches (approx. 0.13 mm).The second section may have a pitch of about 0.01 inches (approx. 0.25mm). The third section may have a pitch of about 0.02 inches (approx.0.51 mm). The fourth section may have a pitch of about 0.04 inches(approx. 1 mm). The fifth section may have a pitch of about 0.08 inches(approx. 2 mm). The sixth section may have a pitch of about 0.016 inches(approx. 4 mm). The first section may be a distal-most section of thehypotube. The first section may be 20% of the hypotube. The secondsection may be proximal to the first section. The second section may be15% of the hypotube. The third section may be proximal to the secondsection. The third section may be 15% of the hypotube. The fourthsection may be proximal to the third section. The fourth section may be15% of the hypotube. The fifth section may be proximal to the fourthsection. The fifth section may be 15% of the hypotube. The sixth sectionmay be proximal to the fifth section. The sixth section may be 20% ofthe hypotube. The first pattern and the second pattern may be laser-cut.

In some embodiments, a device for treating a thrombus in a vesselcomprises a hypotube having a longitudinal axis. The hypotube includes afirst pattern of longitudinally-spaced rows each including two kerfs andtwo stems and a second pattern of longitudinally-spaced rows eachincluding two kerfs and two stems. The two stems in each of the rows ofthe first pattern are circumferentially about 180° apart. The stems ofthe first pattern are offset in a first circumferential direction. Thetwo stems in each of the rows of the second pattern arecircumferentially about 180° apart. The rows of the second pattern areinterspersed with the rows of the first pattern. The stems of the secondpattern are offset in a second circumferential direction opposite thefirst circumferential direction.

The first pattern may be singly alternatingly dispersed with the secondpattern. Each of the rows may be angled with respect to the longitudinalaxis of the hypotube. The kerfs in each of the rows of the first patternand the second pattern may have rounded edges. A pitch of thelongitudinally-spaced rows of the first pattern and the second patternmay vary longitudinally along the hypotube. The hypotube may include afirst section, a second section, a third section, a fourth section, afifth section, and a sixth section. The first section may have a pitchof about 0.005 inches (approx. 0.13 mm). The second section may have apitch of about 0.01 inches (approx. 0.25 mm). The third section may havea pitch of about 0.02 inches (approx. 0.51 mm). The fourth section mayhave a pitch of about 0.04 inches (approx. 1 mm). The fifth section mayhave a pitch of about 0.08 inches (approx. 2 mm). The sixth section mayhave a pitch of about 0.016 inches (approx. 4 mm). The first section maybe a distal-most section of the hypotube. The first section may be 20%of the hypotube. The second section may be proximal to the firstsection. The second section may be 15% of the hypotube. The thirdsection may be proximal to the second section. The third section may be15% of the hypotube. The fourth section may be proximal to the thirdsection. The fourth section may be 15% of the hypotube. The fifthsection may be proximal to the fourth section. The fifth section may be15% of the hypotube. The sixth section may be proximal to the fifthsection. The sixth section may be 20% of the hypotube. The first patternand the second pattern may be laser-cut.

In some embodiments, a device for treating a thrombus in a vesselcomprises a hypotube including a first pattern of longitudinally-spacedrows each including two kerfs and two stems and a second pattern oflongitudinally-spaced rows each including two kerfs and two stems. Thestems of the first pattern are offset in a first circumferentialdirection. The rows of the second pattern are interspersed with the rowsof the first pattern. The stems of the second pattern are offset in asecond circumferential direction opposite the first circumferentialdirection.

The two stems in each of the rows of the first pattern may becircumferentially about 180° apart. The two stems in each of the rows ofthe second pattern may be circumferentially about 180° apart. Thehypotube may have a longitudinal axis. A pitch of thelongitudinally-spaced rows of kerfs may vary along the longitudinal axisof the hypotube. The first pattern may be singly alternatingly dispersedwith the second pattern. Each of the rows may be angled with respect tothe longitudinal axis of the hypotube. The kerfs in each of the rows ofthe first pattern and the second pattern may have rounded edges. Thefirst pattern and the second pattern may be laser-cut. The hypotube maycomprise stainless steel or nitinol.

In some embodiments, a method of manufacturing a thrombus treatmentdevice comprises arranging a plurality of spools on a yarn wheel,braiding the radiopaque wires and the shape memory wires in aone-over-one-under-one pattern around a first mandrel to form a textilestructure, shape setting the textile structure in a substantiallycylindrical shape, securing the shape-set textile structure on a secondmandrel including bulbs and necks, shape setting the shape-set textilestructure on the second mandrel, and removing the shape-set textilestructure from the second mandrel. At least some of the spools includingradiopaque wires and at least some of the spools include shape memorywires.

Securing the shape-set textile structure on the second mandrel mayinclude wrapping wire around the necks of the second mandrel. Theradiopaque wires may include platinum tungsten wires. The shape memorywires may include nickel titanium wires. The method may further comprisebonding the shape-set textile structure to a delivery system. Bondingthe shape-set textile structure to the delivery system may compriseinlay bonding. The method may further comprise, before bonding theshape-set textile structure to the delivery system, positioning thewires in a pinch ring or a pinch cylinder. Bonding the shape-set textilestructure to the delivery system may comprise overlay bonding. Bondingthe shape-set textile structure to the delivery system may comprisebonding a proximal end of the shape-set textile structure to a distalend of the delivery system. Bonding the shape-set textile structure tothe delivery system may comprise bonding a distal end of the shape-settextile structure to a distal end of the delivery system. Bonding theshape-set textile structure to the delivery system may comprise placinga tubing around a bonding area. Bonding the shape-set textile structureto the delivery system may comprise soldering the shape-set textilestructure to the cut hypotube. The delivery system may comprise a cuthypotube. The delivery system may comprise a hypotube including a firstpattern and a second pattern.

In some embodiments, a method of manufacturing a thrombus treatmentdevice comprises cutting a first pattern of longitudinally-spaced rowseach including two kerfs and two stems into a hypotube and cutting asecond pattern of longitudinally-spaced rows each including two kerfsand two stems into the hypotube. The two stems in each of the rows ofthe first pattern are circumferentially about 180° apart. The stems ofthe first pattern are offset in a first circumferential direction. Thetwo stems in each of the rows of the second pattern arecircumferentially about 180° apart. The stems of the second pattern areoffset in a second circumferential direction opposite the firstcircumferential direction. The second pattern is singly alternatinglyinterspersed with the first pattern.

Cutting the first pattern and cutting the second pattern may comprisecutting rounded edges of the kerfs in each of the rows of the firstpattern and the second pattern. Cutting the first pattern and cuttingthe second pattern may comprise cutting each of the rows of the firstpattern and the second pattern at an angle with respect to alongitudinal axis of the hypotube. The hypotube may comprise stainlesssteel. The method may further comprise bonding the hypotube to ashape-set textile structure. The shape-set textile structure may includea plurality of bulbs.

In some embodiments, a method of treating a thrombus in a vesselcomprises measuring a length of the thrombus in the vessel and advancinga microcatheter in the vessel. Advancing the microcatheter includescrossing the thrombus with a distal end of the microcatheter. The methodfurther comprises inserting a thrombectomy device in a radiallycompressed state from an introducer sheath into the microcatheter. Thethrombectomy device includes a textile structure including a pluralityof filaments woven to form a plurality of self-expanding bulbs. At leasttwo of the plurality of filaments comprise radiopaque material andconfigured to form crossing points visible under x-ray. The crossingpoints are configured to provide approximate length measurement of anexpanded length of the thrombectomy device. The method furthercomprises, after inserting the thrombectomy device from the introducersheath into the microcatheter, advancing the thrombectomy device in thevessel and through the microcatheter proximate to the distal end of themicrocatheter. Advancing the thrombectomy device includes crossing thethrombus with the distal-most bulb of the plurality of self-expandingbulbs. The method further comprises, after advancing the thrombectomydevice, retracting the microcatheter to unsheathe a length of thethrombectomy device. Upon being unsheathed from the microcatheter, atleast some of the plurality of self-expanding bulbs of the elongatesupport structure of the thrombectomy device self-expand from theradially compressed state to a radially expanded state. Retracting themicrocatheter is at least until the length of the thrombectomy device isat least as long as the measured length of the thrombus in the vessel.The method further comprises entrapping the thrombus in the unsheathedself-expanding bulbs, after entrapping the thrombus in the unsheathedself-expanding bulbs, removing the thrombus from the vessel insubstantially one piece using the thrombectomy device, measuring alength of the thrombus out of the vessel, and comparing the length ofthe thrombus in the vessel to the length of the thrombus out of thevessel.

The method may further comprise, after retracting the microcatheter,torsionally rasping the thrombectomy device, wherein torsionally raspingthe thrombectomy device may include entrapping the thrombus in theunsheathed self-expanding bulbs. The vessel may comprise a blood vesselin a brain, leg, or other vessel or structure in the body. [0048] Insome embodiments, a method of treating a thrombus in a vessel comprisesmeasuring a length of the thrombus in the vessel and expanding a lengthof a thrombectomy device in the vessel proximate to the thrombus. Theexpanded length of the thrombectomy device is based at least partiallyon the measured length of the thrombus in the vessel.

Measuring the length of the thrombus in the vessel may comprise at leastone of computerized axial tomography (CAT) scan digital imagingmeasurement, CAT scan angiogram, magnetic resonance imaging (MRI)angiogram, and catheter angiogram. Expanding the length of thethrombectomy device may include retracting a sheath from around thethrombectomy device. Retracting the sheath may be for a length greaterthan the expanded length of the thrombectomy device. The thrombectomydevice may comprise a plurality of filaments woven into a textilestructure. At least two of the plurality of filaments may includeradiopaque material configured to form crossing points visible underx-ray. The crossing points may be configured to provide approximatelength measurement of the expanded length of the thrombectomy device.The thrombectomy device may include a plurality of self-expanding bulbs.After expanding the length of the thrombectomy device, at least one ofthe plurality of self-expanding bulbs may be distal to the thrombus.After expanding the length of the thrombectomy device, at least two ofplurality of bulbs may have different outer diameters. The method mayfurther comprise removing the thrombus from the vessel in substantiallyone piece using the thrombectomy device, measuring a length of thethrombus out of the vessel, and comparing the length of the thrombus inthe vessel to the length of the thrombus out of the vessel. The methodmay further comprise, if the length of the thrombus out of the vessel isless than the length of the thrombus in the vessel, removing remainingthrombus from the vessel. Measuring the length of the thrombus out ofthe vessel may comprise placing the thrombus proximate to a ruler on apackage of the thrombectomy device. The vessel may comprise a bloodvessel in a brain, leg, or other vessel or structure in the body.

In some embodiments, a method of treating a thrombus in a vesselcomprises measuring a length of the thrombus in the vessel, removing thethrombus from the vessel in substantially one piece using a thrombectomydevice, measuring a length of the thrombus out of the vessel, andcomparing the length of the thrombus in the vessel to the length of thethrombus out of the vessel.

The method may further comprise, if the length of the thrombus out ofthe vessel is less than the length of the thrombus in the vessel,removing remaining thrombus from the vessel. Measuring the length of thethrombus in the vessel may comprise at least one of computerized axialtomography (CAT) scan digital imaging measurement, CAT scan angiogram,magnetic resonance imaging (MRI) angiogram, and catheter angiogram.Measuring the length of the thrombus out of the vessel may compriseplacing the thrombus proximate to a ruler on a package of thethrombectomy device. The vessel may comprise a blood vessel in a brain,leg, or other vessel or structure in the body.

In some embodiments, a method of treating a thrombus in a vesselcomprises advancing a microcatheter in the vessel including crossing adistal end of the thrombus with a distal end of the microcatheter, and,after advancing the microcatheter, inserting a thrombectomy device in aradially compressed state into the microcatheter. The thrombectomydevice includes a plurality of wires woven to form a textile fabricincluding a first shape upon advancing out of the microcatheter and asecond shape upon exposure to a temperature or lower. The method furthercomprises, after inserting the thrombectomy device into themicrocatheter, advancing the thrombectomy device in the vessel andthrough the microcatheter proximate to the distal end of themicrocatheter, and, after advancing the thrombectomy device, maintaininga location of a proximal portion of the thrombectomy device whileproximally retracting the microcatheter. Upon being unsheathed from themicrocatheter, the textile fabric changes from the radially compressedshape to the first shape. The method further comprises, after retractingthe microcatheter, injecting fluid at the temperature or lower. Uponbeing contact with the temperature or lower, the textile fabric changesto the second shape. The method further comprises, while the textilestructure is in the second shape, torsionally rasping the thrombectomydevice, and, after torsionally rasping the thrombectomy device,retracting at a similar rate the microcatheter and the proximal portionof the thrombectomy device.

The first shape may comprise a plurality of bulbs and the second shapemay comprise a spiral. The first temperature may be less than about 25°C. (e.g., about 18° C.). The textile fabric may include a third shapeupon exposure to a second temperature or higher. The first shape maycomprise an expanded cylinder, the second shape may comprise a spiral,and the third shape may comprise a plurality of bulbs. The secondtemperature may be greater than about 25° C. (e.g., about 37° C.).Torsionally rasping the thrombectomy device may include at least one ofremoving portions of the thrombus attached to an endothelium wall,entrapping the thrombus in the radially expanded distal portion of thethrombectomy device, and collecting emboli in the radially expandeddistal portion of the thrombectomy device. The vessel may comprise ablood vessel in a brain, leg, or other vessel or structure in the body.

In some embodiments, a method of treating a thrombus in a vesselcomprises advancing a thrombectomy device in a radially compressed statein the vessel and through a microcatheter until the thrombectomy isproximate to a distal end of the microcatheter and a distal end of thethrombus. The thrombectomy device includes a plurality of wires woven toform a textile fabric including a first shape upon advancing out of themicrocatheter and a second shape upon exposure to a temperature orhigher. The method further comprises, after advancing the thrombectomydevice, maintaining a location of a proximal portion of the thrombectomydevice while proximally retracting the microcatheter. Upon beingunsheathed from the microcatheter, the textile fabric changes from theradially compressed shape to the first shape and wherein upon beingexposed to the temperature or higher the textile fabric changes from thefirst shape to the second shape. The method further comprises entrappingthe thrombus in the second state.

The first shape may comprise a cylinder and the second shape maycomprise a plurality of bulbs. The second shape may comprise at leasttwo of the plurality of bulbs may have different outer diameters,different shapes, or different outer diameters and different shapes. Thesecond shape may be tapered. The second shape may comprise at least twoof the plurality of bulbs separated by a neck. The first shape maycomprise a cylinder and the second shape may comprise a spiral.Entrapping the thrombus may include torsionally rasping the thrombectomydevice. The vessel may comprise a blood vessel in a brain, leg, or othervessel or structure in the body.

In some embodiments, a method of treating a thrombus in a vesselcomprises advancing a thrombectomy device in a radially compressed statein the vessel and through a microcatheter until the thrombectomy isproximate to a distal end of the microcatheter and a distal end of thethrombus. The thrombectomy device includes a first shape upon advancingout of the microcatheter, a second shape upon exposure to a firsttemperature or lower, and a third shape upon exposure to a secondtemperature or higher. The method further comprises, after advancing thethrombectomy device, maintaining a location of a proximal portion of thethrombectomy device while proximally retracting the microcatheter. Uponbeing unsheathed from the microcatheter, the thrombectomy device changesfrom the radially compressed shape to the first shape. The methodfurther comprises, after retracting the microcatheter, injecting fluidat the temperature or lower. Upon contact with the first temperature orlower, the thrombectomy device changes to the second shape. The methodfurther comprises, upon exposure to the second temperature or higher,the thrombectomy device changes to the third shape.

The thrombectomy device may comprise a textile structure including thefirst shape, the second shape, and the third shape. The thrombectomydevice may comprise a laser cut structure including the first shape, thesecond shape, and the third shape. At least one of the first shape andthe second shape may be non-cylindrical.

In some embodiments, a method of coupling a woven tubular device to ahypotube comprises inserting a proximal end of the woven tubular deviceinto a distal end of the hypotube. The woven tubular device includes aplurality of self-expanding bulbs. The hypotube includes a plurality ofkerfs. The method further comprises inserting a delivery deviceincluding a J-shaped tube proximate to the proximal end of the woventubular device through a distal-most kerf of the plurality of kerfs,delivering solder from the delivery device at a first location andbetween the woven tubular structure and the hypotube, moving thedelivery device to a second location circumferentially spaced about 180°from the first location, delivering solder from the delivery device atthe second location and between the woven tubular structure and thehypotube, moving the delivery device to a third locationcircumferentially spaced about 90° from the first location and from thesecond location, delivering solder from the delivery device at the thirdlocation and between the woven tubular structure and the hypotube,moving the delivery device to a fourth location circumferentially spacedabout 90° from the first location and from the second location and about180° from the third location, delivering solder from the delivery deviceat the fourth location and between the woven tubular structure and thehypotube, and allowing the solder to cool. The solder may comprisesilver-based lead-free solder.

In some embodiments, a method of coupling a woven tubular device to ahypotube comprises inserting a proximal end of the woven tubular deviceinto a distal end of the hypotube. The hypotube includes a plurality ofkerfs. The method further comprises delivering bonding material from thedelivery device between the woven tubular structure and the hypotube inat least one circumferential location. Delivering the solder includesinserting the delivery device including a J-shaped tube proximate to theproximal end of the woven tubular device through a distal-most kerf ofthe plurality of kerfs.

The bonding material may comprise at least one of solder and epoxy. Thesolder may comprise silver-based lead-free solder. The solder maycomprise gold-based lead-free solder. Delivering the bonding materialmay include delivering the bonding material fully arcuately. Deliveringthe bonding material may include delivering the bonding material in aplurality of circumferentially spaced locations. Delivering the bodingmaterial in the plurality of circumferentially spaced locations mayinclude delivering bonding material from the delivery device at a firstlocation and between the woven tubular structure and the hypotube,moving the delivery device to a second location circumferentially spacedabout 180° from the first location, delivering bonding material from thedelivery device at the second location and between the woven tubularstructure and the hypotube, moving the delivery device to a thirdlocation circumferentially spaced about 90° from the first location andfrom the second location, delivering bonding material from the deliverydevice at the third location and between the woven tubular structure andthe hypotube, moving the delivery device to a fourth locationcircumferentially spaced about 90° from the first location and from thesecond location and about 180° from the third location, and deliveringbonding material from the delivery device at the fourth location andbetween the woven tubular structure and the hypotube. The proximal endof the woven tubular device may include a proximal segment including asleeve around filaments of the woven tubular device and a distal segmentincluding exposed filaments of the woven tubular device. Thecircumferential location may include at least parts of the proximalsegment and the distal segment. The proximal end of the woven tubulardevice may include a first segment including a ring around filaments ofthe woven tubular device, a second segment distal to the first segmentincluding exposed filaments of the woven tubular device, and a thirdsegment proximal to the first segment including exposed filaments of thewoven tubular device. The circumferential location may include at leastparts of the first segment and at least one of the second segment andthe third segment. The rings may be crimped around the filaments. Thefilaments may be welded to the ring.

In some embodiments, a method of coupling a woven tubular device to ahypotube comprises inserting a distal end of the hypotube into aninterior of the woven tubular device at a longitudinal location anddelivering bonding material between the woven tubular device and thehypotube at the longitudinal location.

The method may further comprise positioning a sleeve around the woventubular device at the location. The bonding material may comprise atleast one of solder and epoxy. After coupling, the distal end of thehypotube may be proximate to a proximal end of the woven tubular device.After coupling, the distal end of the hypotube may be proximate to adistal end of the woven tubular device. The woven tubular device mayinclude a plurality of bulbs. After coupling, the distal end of thehypotube may be proximal to a distal-most bulb.

In some embodiments, a method of manufacturing a thrombus treatmentdevice comprises arranging a plurality of spools on spindles on a yarnwheel. At least some of the spools include radiopaque wires and at leastsome of the spools including shape memory wires. The method furthercomprises attaching an end of each of the wires to a ring over a firstmandrel and braiding the radiopaque wires and the shape memory wires ina one-over-one-under-one pattern around the first mandrel to form atextile structure. Braiding includes at least one of rotating the yarnwheel, rotating the spindles, and longitudinally extending the ringalong the first mandrel away from the yarn wheel. The method furthercomprises shape setting the textile structure into a substantiallycylindrical shape, securing the shape-set textile structure on a secondmandrel including bulbs and necks, shape setting the shape-set textilestructure on the second mandrel, and removing the shape-set textilestructure from the second mandrel.

Securing the shape-set textile structure on the second mandrel mayinclude wrapping at least one of wire and bangles around the necks ofthe second mandrel. The method may further comprise forming the secondmandrel. Forming the mandrel may include stringing bulbs along a wire.Stringing the bulbs along the wire may include selecting shapes of thebulbs, sizes of the bulbs, and spacing between the bulbs. Forming themandrel may include stringing hypotubes along the wire and between atleast some of the bulbs. Arranging the plurality of spools may includepositioning at least two of the spools including radiopaque wiresadjacent to each other. The method may further comprise bonding theshape-set textile structure to a hypotube.

In some embodiments, a method of manufacturing a thrombus treatmentdevice comprises arranging a plurality of spools of wire on spindles ona yarn wheel, braiding the wires a mandrel including bulbs and necks toform a textile structure, shape setting the textile structure on themandrel, and removing the shape-set textile structure from the mandrel.

The method may further comprise securing the textile structure on themandrel before shape setting. The method may further comprise formingthe mandrel. Forming the mandrel may include stringing bulbs along awire. Stringing the bulbs along the wire may include selecting shapes ofthe bulbs, sizes of the bulbs, and spacing between the bulbs. Formingthe mandrel may include stringing hypotubes along the wire and betweenat least some of the bulbs. The method may further comprise bonding theshape-set textile structure to a hypotube.

In some embodiments, a method of manufacturing a thrombus treatmentdevice comprises arranging a plurality of spools on spindles on a yarnwheel. At least some of the spools include radiopaque wires and at leastsome of the spools include shape memory wires. Arranging the pluralityof spools includes positioning at least two of the spools includingradiopaque wires adjacent to each other. The method further comprisesbraiding the radiopaque wires and the shape memory wires to form atextile structure.

The textile structure may include two sine waves of radiopaque wiresoffset by about 180°. The textile structure may include three sine wavesof radiopaque wires offset by about 120°. The textile structure mayinclude a first sine wave of radiopaque wires, a second sine wave ofradiopaque wires offset from the first sine wave by about 180°, a thirdsine wave of radiopaque wires offset from the first sine wave by about7.5°, and a fourth sine wave of radiopaque wires offset from the thirdsine wave by about 7.5°. The method may further comprise bonding theshape-set textile structure to a hypotube.

In some embodiments, a method of manufacturing a thrombus treatmentdevice comprises holding a hypotube using at least one bushing and atleast one collet and cutting a pattern including a plurality of kerfsinto the hypotube. Cutting the pattern includes directing a focusedlaser beam at the hypotube and longitudinally and rotationally movingthe hypotube in a design such that the focused laser beam cuts thehypotube to form the plurality of kerfs. The focused laser creates aheat impact puddle. The heat impact puddle is less than a width and alength of each of the plurality of kerfs. The method further comprises,during cutting the pattern, flowing fluid through the hypotube.

Directing the focused laser beam may include creating the heat impactpuddle inward of edges of the plurality of kerfs. Cutting the patternmay include cutting away the heat impact puddle. Directing the focusedlaser beam may include creating the heat impact puddle at edges of theplurality of kerfs. Directing the focused laser beam may includecreating the heat impact puddle at corners of the plurality of kerfs.The design may include outlining edges of the plurality of kerfs. Thedesign may include moving the hypotube may include relatively moving thefocused laser beam diagonal to the plurality of kerfs. The design mayinclude a spiral. Holding the hypotube may comprise using at least onebushing comprising an aperture may have a diameter at least about 0.001inches greater than an outer diameter of the hypotube. Holding thehypotube may comprise using at least one collet comprising an aperturemay have a diameter at least about 0.001 inches greater than an outerdiameter of the hypotube. Holding the hypotube may comprise adjusting adiameter of an aperture of the collet(s). Flowing the fluid may includeadjusting a height of a reservoir containing the fluid. Flowing thefluid may include adjusting a height of a water inlet gate between areservoir containing the fluid and the hypotube.

In some embodiments, a method of manufacturing a thrombus treatmentdevice comprises cutting a pattern including a plurality of rows ofkerfs into the hypotube. Cutting the pattern includes directing afocused laser beam at the hypotube and longitudinally and rotationallymoving the hypotube such that the focused laser beam cuts the hypotubeto form the plurality of kerfs. The focused laser creates a heat impactpuddle. The heat impact puddle is inward of edges of the plurality ofkerfs.

The method may further comprise flowing fluid through the hypotube. Themethod may further comprise holding a hypotube using at least one of abushing and a collet.

In some embodiments, a method of manufacturing a thrombus treatmentdevice comprises cutting a pattern into the hypotube and, during cuttingthe pattern, flowing fluid through the hypotube. The pattern includes afirst pattern of longitudinally-spaced rows each including two kerfs andtwo stems and a second pattern of longitudinally-spaced rows eachincluding two kerfs and two stems. The two stems in each of the rows ofthe first pattern are circumferentially about 180° apart. The stems ofthe first pattern are offset in a first circumferential direction. Thetwo stems in each of the rows of the second pattern arecircumferentially about 180° apart. The rows of the second pattern areinterspersed with the rows of the first pattern. The stems of the secondpattern are offset in a second circumferential direction opposite thefirst circumferential direction.

Each of the rows may be angled with respect to a longitudinal axis ofthe hypotube. The kerfs in each of the rows of the first pattern and thesecond pattern may have rounded edges. A pitch of thelongitudinally-spaced rows of the first pattern and the second patternmay varies longitudinally along the hypotube.

In some embodiments, a device for treating a thrombus in a vesselcomprises a plurality of wires woven to form a self-expanding textilestructure. The plurality of wires includes shape-memory wires and atleast two radiopaque wires forming at two offset sine waves.

Crossings of the at least two sine waves ray may be substantiallyuniformly spaced. At least one of the at least two sine waves mayinclude a plurality of radiopaque wires. Each of the at least two sinewaves may include a plurality of radiopaque wires. The at least two sinewaves may be offset by about 180°. The at least two sine waves mayinclude three sine waves offset by about 120°. The textile structure mayinclude a plurality of bulbs.

In some embodiments, a device for treating a thrombus in a vesselcomprises a plurality of wires woven to form a textile structureincluding a plurality of bulbs. The textile structure includes a distalend including an end treatment.

The end treatment may comprise a polymer coating. The polymer maycomprise radiopaque particles. The end treatment may comprise aradiopaque marker. The distal end may be radially inward of theplurality of bulbs.

In some embodiments, a device for treating a thrombus in a vesselcomprises a plurality of wires woven to form a textile structureincluding a plurality of bulbs and necks between the bulbs. The necksare circumferentially offset around textile structure.

Each of the plurality of bulbs may have a generally circularcross-section in a radially expanded state. The necks may be alignedalong chords of the bulbs. Each of the plurality of bulbs may have agenerally spherical shape in a radially expanded state. The necks may bealigned along chords of the spheres. The necks may alternate about 180°between a first longitude and a second longitude. The necks maycircumferentially rotate about 120° between each of the bulbs. The necksmay circumferentially rotate about 90° between each of the bulbs. Eachof the plurality of bulbs may have a generally polygonal cross-sectionin a radially expanded state. The necks may be aligned along apices ofthe bulbs.

In some embodiments, a device for treating a thrombus in a vesselcomprises a plurality of wires woven to form a textile structure. Thetextile structure includes a first shape at a first temperature, asecond shape at a second temperature higher than the first temperature,and a third shape including stress-induced martensite.

The third shape may comprise a cylindrical shape. The stress-inducedmartensite may be induced by inner sidewalls of a sheath. The firstshape may comprise a spiral. The second shape may comprise a pluralityof bulbs. The first temperature may be less than about 25° C. (e.g.,about 18° C.). The second temperature may be at least about 25° C.(e.g., about 37° C.).

In some embodiments, a device for treating a thrombus in a vesselcomprises a plurality of wires woven to form a textile structure. Thetextile structure includes a first shape at a first temperature, asecond shape at a second temperature higher than the first temperature,and a third shape at a third temperature higher than the secondtemperature.

The second shape may comprise a cylindrical shape. The third shape maycomprise a plurality of bulbs. The first shape may comprise a spiral.The first temperature may be less than about 25° C. (e.g., about 18°C.). The second temperature may be between about 25° C. and about 37° C.The third temperature may be at least about 37° C.

In some embodiments, a method of forming a device for treating athrombus in a vessel comprises heat treating a structure to impart afirst shape to the structure at a first temperature. The structureincludes shape memory material. The method further comprises heattreating the structure to impart a second shape to the structure andheat treating the structure to impart a third shape to the structure.

The method may further comprise weaving a plurality of wires to form thestructure, at least some of the plurality of wires including the shapememory material. The method may further comprise selecting temperaturesof the heat treating based at least partially on a composition of theshape memory material. Heat treating the structure to impart the firstshape may be at a temperature between about 400° C. and about 450° C.for about 2 minutes to about 10 minutes. Heat treating the structure toimpart the second shape may be at a temperature between about 500° C.and about 550° C. for about 20 minutes to about 180 minutes. Heattreating the structure to impart the first shape may be at a temperaturebetween about 400° C. and about 450° C. for about 3 minutes to about 10minutes. Heat treating the structure to impart the first shape may be ata temperature between about 500° C. and about 550° C. for about 5minutes to about 10 minutes. Heat treating the structure to impart thesecond shape may be at a temperature between about 400° C. and about450° C. for about 3 minutes to about 10 minutes. Heat treating thestructure to impart the first shape may be at a temperature betweenabout 500° C. and about 550° C. for about 3 minutes to about 10 minutes.The second shape may comprise a plurality of bulbs. The third shape maycomprise a spiral.

In some embodiments, a catheter comprises a hypotube including having alongitudinal axis. The hypotube includes a working lumen, a firstpattern including a plurality of longitudinally-spaced rows eachincluding two kerfs and two stems offset in a first circumferentialdirection, and a second pattern including a plurality oflongitudinally-spaced rows each including two kerfs and two stems offsetin a second circumferential direction opposite the first circumferentialdirection. The rows of the second pattern are singly alternatinglyinterspersed with the rows of the first pattern. A pitch of thelongitudinally-spaced kerfs of first pattern and the second pattern varyalong the longitudinal axis of the hypotube.

The hypotube may include a first section, a second section, a thirdsection, a fourth section, a fifth section, and a sixth section. Thefirst section may have a pitch of about 0.005 inches (approx. 0.13 mm).The second section may have a pitch of about 0.01 inches (approx. 0.25mm). The third section may have a pitch of about 0.02 inches (approx.0.51 mm). The fourth section may have a pitch of about 0.04 inches(approx. 1 mm). The fifth section may have a pitch of about 0.08 inches(approx. 2 mm). The sixth section may have a pitch of about 0.016 inches(approx. 4 mm). The first section may be a distal-most section of thehypotube. The first section may be 20% of the hypotube. The secondsection may be proximal to the first section. The second section may be15% of the hypotube. The third section may be proximal to the secondsection. The third section may be 15% of the hypotube. The fourthsection may be proximal to the third section. The fourth section may be15% of the hypotube. The fifth section may be proximal to the fourthsection. The fifth section may be 15% of the hypotube. The sixth sectionmay be proximal to the fifth section. The sixth section may be 20% ofthe hypotube. The first pattern and the second pattern may be laser-cut.The catheter may further comprise a polymer coating on at least aportion of an outside of the hypotube. At least one parameter of thepolymer may vary along the longitudinal axis of the hypotube. Theparameter(s) may be selected from the group consisting of one or moreof: material, thickness, and durometer. The variation of parameter(s) ofthe polymer may be aligned with the variation of the pitch of thelongitudinally-spaced kerfs. The catheter may further comprise a polymercoating on at least a portion of an inside of the hypotube. The hypotubemay comprise stainless steel. The hypotube may comprise a shape memorymaterial. Each of the kerfs may include rounded edges. Each of the rowsmay be at an angle with respect to the longitudinal axis of thehypotube.

In some embodiments, a catheter comprises a hypotube including having alongitudinal axis, a first polymer coating radially outward of at leasta portion of an outside of the hypotube, and a second polymer coatingradially inward of at least a portion of an inside of the hypotube. Thehypotube includes at least one pattern including a plurality oflongitudinally-spaced rows each including two kerfs and two stems offsetin a first circumferential direction.

The first polymer may be different from the second polymer. At least oneparameter of the first polymer coating may vary along the longitudinalaxis of the hypotube. The parameter(s) may be selected from the groupconsisting of one or more of: material, thickness, and durometer. Thepattern may include a first pattern including a plurality oflongitudinally-spaced rows each including two kerfs and two stems offsetin a first circumferential direction and a second pattern including aplurality of longitudinally-spaced rows each including two kerfs and twostems offset in a second circumferential direction opposite the firstcircumferential direction. The rows of the second pattern may be singlyalternatingly interspersed with the rows of the first pattern. A pitchof the longitudinally-spaced kerfs may vary along the longitudinal axisof the hypotube.

In some embodiments, a catheter comprises a hypotube having alongitudinal axis and a polymer coating over at least a portion of anoutside of the hypotube. The hypotube includes at least one patternincluding a plurality of longitudinally-spaced rows each including twokerfs and two stems offset in a first circumferential direction. A pitchof the longitudinally-spaced kerfs varies along the longitudinal axis ofthe hypotube. At least one parameter of the polymer coating varies alongthe longitudinal axis of the hypotube. The parameter(s) may be selectedfrom the group consisting of at least one of material, thickness, anddurometer.

The variation of the parameter(s) of the polymer may be aligned with thevariation of the pitch of the longitudinally-spaced kerfs. The polymercoating may be hydrophobic. The catheter may further comprise an innerpolymer coating at least a portion of an inside of the hypotube.

In some embodiments, a system for heat treating a device comprises achamber configured to contain bath media, a container within the chamberand configured to hold the device, an air inlet gate fluidly upstream ofthe chamber and configured to be coupled to a gas source to flow gasinto the chamber to fluidize the bath media, a heating element betweenthe air inlet gate and the chamber, and a porous plate between the airinlet gate and the chamber. The chamber includes a detachable flange.The container is mechanically coupled to the detachable flange.

The bath media may include sand. The bath media may includenon-flammable particles. The porous plate may be between the heatingelement and the air inlet gate. The detachable flange may include aconduit configured to allow passage of an arm mechanically coupling thecontainer and the detachable flange. Adjustment of a length of the armmay adjust a height of the container in the basket. Temperature in thechamber may vary vertically with distance from the heating device. Thesystem may further comprise an air inflow regulator coupled to the airinlet gate. A height of the air inflow regulator may be adjustable toadjust a velocity of the gas into the chamber. The gas source maycomprise nitrogen. The gas source may comprise air. The gas source maycomprise hydrogen. The gas source may comprise carbon monoxide.

In some embodiments, a system for heat treating a device comprises achamber configured to contain bath media, a container within the chamberand configured to hold the device, an air inlet gate fluidly upstream ofthe chamber and configured to be coupled to a gas source to flow gasinto the chamber to fluidize the bath media, a heating element betweenthe air inlet gate and the chamber, and a temperature regulatorconfigured to regulate temperature in the chamber by adjusting at leastone of the air inlet gate and the heating element. The system mayfurther comprise thermal sensors electrically connected to thetemperature regulator.

In some embodiments, a system for heat treating a device comprises achamber configured to contain bath media, a container within the chamberand configured to hold the device, and an arm mechanically coupling thechamber to the detachable flange. Gas flow into the chamber isconfigured to fluidize the bath media. The chamber includes a detachableflange including a handle. A height of the container is adjustable inseveral embodiments.

The arm may comprise at least one of a wire, a plurality of wires, and ahypotube. Adjustment of a length of the arm may adjust the height of thecontainer in the basket. Detachment of the detachable flange may allowremoval of the container from the chamber. The system may furthercomprise air-sealant rivets on at least one of an inner surface of thedetachable flange and an outer surface of the detachable flange.

In some embodiments, a system for cutting a hypotube comprises a laserconfigured to produce a focused laser beam, a bushing configured to atleast partially support a hypotube, a collet configured to at leastpartially support the hypotube, a fluid flow system, and a conveyorsystem configured to longitudinally advance the hypotube. The colletincludes an adjustable diameter aperture. The fluid flow system includesa water inlet device and a water inlet gate configured to be fluidlycoupled to an end of the hypotube.

The focused laser beam may have a widest dimension less than a narrowestdimension of a pattern to be cut. The focused laser beam may have awidest dimension no more than about 120% greater than a narrowestdimension of a pattern to be cut. The bushing may include an aperturemay have a diameter at least about 0.001 inches (approx. 0.025 mm)greater than an outer diameter of the hypotube. The collet may includean aperture may have a diameter at least about 0.001 inches (approx.0.025 mm) greater than an outer diameter of the hypotube. The waterinlet device may have an adjustable height. The water inlet gate mayhave an adjustable height. The laser may comprise a YAG laser. The lasermay have a wavelength of about 1060 nm or less.

In some embodiments, a system for cutting a hypotube comprises a fluidflow system, a conveyor system configured to longitudinally advance thehypotube, and at least one of a bushing and a collet configured to atleast partially support the hypotube. The fluid flow system includes awater inlet device and a water inlet gate configured to be fluidlycoupled to an end of the hypotube.

The collet may include an adjustable diameter aperture. The bushing mayinclude an aperture may have a diameter at least about 0.001 inches(approx. 0.025 mm) greater than an outer diameter of the hypotube. Thecollet may include an aperture may have a diameter at least about 0.001inches (approx. 0.025 mm) greater than an outer diameter of thehypotube. The water inlet device may have an adjustable height. Thewater inlet gate may have an adjustable height. A plurality of bushingsand collets longitudinally may be spaced so that sag of the hypotube maybe less than about 3% of a height of the hypotube.

In some embodiments, a system for cutting a hypotube comprises a fluidflow system including a water inlet device may have an adjustable heightand a water inlet gate may have an adjustable height and configured tobe fluidly coupled to an end of a hypotube. The water inlet device mayinclude a plurality of reservoirs. The plurality of reservoirs may bevertically stacked and fluidly coupled. The water inlet gate may beconfigured to adjust fluid flow based on a height of the water inletdevice.

The methods summarized above and set forth in further detail belowdescribe certain actions taken by a practitioner; however, it should beunderstood that they can also include the instruction of those actionsby another party. Thus, actions such as “advancing a guidewire” include“instructing the advancement of a guidewire.”

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic side elevational view of an example embodiment ofa vascular treatment device.

FIG. 1B is a schematic side elevational view of another exampleembodiment of a vascular treatment device.

FIG. 1C is a schematic side elevational view of yet another exampleembodiment of a vascular treatment device.

FIG. 1D is a schematic side elevational view of still another exampleembodiment of a vascular treatment device.

FIG. 2A is a schematic side elevational view of an example embodiment ofa distal portion of a vascular treatment device.

FIG. 2B is a schematic side elevational view of another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 2C is a perspective view of the distal portion of FIG. 2B.

FIG. 2D is a photograph illustrating the distal portion of FIG. 2B.

FIG. 3A is a schematic side elevational view of another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 3B is a schematic side elevational view of another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 3C is a perspective view of the distal portion of FIG. 3B.

FIG. 4A is a schematic side elevational view of another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 4B is a schematic side elevational view of another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 4C is a schematic side elevational view of another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 4D is a schematic proximal end view of the distal portion of FIG.4C.

FIG. 4E is a schematic side elevational view of yet another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 4F is a schematic proximal end view of the distal portion of FIG.4E.

FIG. 4G is a schematic side elevational view of yet another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 4H is a schematic proximal end view of the distal portion of FIG.4G.

FIG. 4I is a schematic side elevational view of still yet anotherexample embodiment of a distal portion of a vascular treatment device.

FIG. 4J is a schematic side elevational view of another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 4K is a schematic side elevational view of yet another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 4L is a schematic side elevational view of still another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 4M is a schematic side elevational view of still yet anotherexample embodiment of a distal portion of a vascular treatment device.

FIG. 4N is a schematic side elevational view of an example square inchof an example embodiment of a distal portion of a vascular treatmentdevice.

FIG. 5A is a schematic side elevational view of another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 5B is a schematic side elevational view of yet another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 5C is a schematic side elevational view of still another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 5D is a schematic side elevational view of still yet anotherexample embodiment of a distal portion of a vascular treatment device.

FIG. 5E is a schematic side elevational view of another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 5F is a schematic side elevational view of yet another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 5G is a schematic side elevational view of still another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 6A is a schematic side elevational view of another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 6B is a schematic side elevational view of yet another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 6C is a schematic side elevational view of still another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 6D is a schematic side elevational view of still yet anotherexample embodiment of a distal portion of a vascular treatment device.

FIG. 6E is a schematic side elevational view of another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 6F is a schematic side elevational view of yet another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 6G is a schematic side elevational view of still another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 6H is a schematic side elevational view of still yet anotherexample embodiment of a distal portion of a vascular treatment device.

FIG. 6I is a schematic side elevational view of another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 6J is a schematic side elevational view of yet another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 7A is a schematic side elevational view of still another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 7B is a schematic side elevational view of still yet anotherexample embodiment of a distal portion of a vascular treatment device.

FIG. 7C is a schematic side elevational view of another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 7D is a schematic side elevational view of yet another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 7E is a schematic side elevational view of still another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 8A is a schematic side perspective view of an example embodiment ofa braiding device.

FIG. 8B is a schematic diagram illustrating an example setup of a braidcarrier mechanism.

FIG. 8C is a schematic diagram illustrating a magnified view of threepairs of spindles in the example setup of the braid carrier mechanism ofFIG. 8B.

FIG. 8D is a photograph illustrating a plurality of filaments beingbraided on a mandrel.

FIG. 8E is a schematic side elevational view of another exampleembodiment of a distal portion of a vascular treatment device.

FIG. 8F is a schematic side elevational view of the distal portion ofFIG. 8E illustrating an example pattern of radiopaque filaments.

FIG. 8G is a schematic diagram illustrating an example setup of a braidcarrier mechanism for forming the distal portion of FIG. 8E.

FIG. 8H is a schematic side elevational view of another exampleembodiment of a distal portion of a vascular treatment deviceillustrating an example pattern of radiopaque filaments.

FIG. 8I is a schematic diagram illustrating an example setup of a braidcarrier mechanism for forming the distal portion of FIG. 8H.

FIG. 8J is a schematic side elevational view of yet another exampleembodiment of a distal portion of a vascular treatment deviceillustrating an example pattern of radiopaque filaments.

FIG. 8K is a schematic diagram illustrating an example setup of a braidcarrier mechanism for forming the distal portion of FIG. 8J.

FIG. 8L is an x-ray photograph illustrating an example of a plurality ofradiopaque filaments of the distal portion of FIG. 8J.

FIG. 8M is a schematic side elevational view of still another exampleembodiment of a distal portion of a vascular treatment deviceillustrating an example pattern of radiopaque filaments.

FIG. 8N is a schematic diagram illustrating an example setup of a braidcarrier mechanism for forming the distal portion of FIG. 8M.

FIG. 8O is a photograph illustrating a plurality of radiopaque filamentsof the distal portion of FIG. 8M on a mandrel.

FIG. 8P is a schematic side elevational view of yet another exampleembodiment of a distal portion of a vascular treatment deviceillustrating an example pattern of radiopaque filaments.

FIG. 8Q is a magnified view of the radiopaque filaments of the distalportion of FIG. 8P.

FIG. 8R is a schematic diagram illustrating an example setup of a braidcarrier mechanism for forming the distal portion of FIG. 8P.

FIG. 8S is an x-ray photograph illustrating an example of a plurality ofradiopaque filaments of the distal portion of FIG. 8P.

FIG. 8T-1 is a schematic side elevational view of still yet anotherexample embodiment of a distal portion of a vascular treatment deviceillustrating an example pattern of radiopaque filaments.

FIG. 8T-2 is a schematic side elevational view of another exampleembodiment of a distal portion of a vascular treatment deviceillustrating an example pattern of radiopaque filaments.

FIG. 8T-3 is a schematic diagram illustrating an example setup of abraid carrier mechanism for forming the distal portions of FIGS. 8T-1and 8T-2.

FIG. 8T-4 is an x-ray photograph illustrating an example of a pluralityof radiopaque filaments of the distal portion of FIG. 8T-2.

FIG. 8U is a schematic side elevational view of another exampleembodiment of a distal portion of a vascular treatment deviceillustrating an example pattern of radiopaque filaments.

FIG. 8V is a schematic diagram illustrating an example setup of a braidcarrier mechanism for forming the distal portion of FIG. 8U.

FIG. 8W is a magnified view of the distal portion of FIG. 8U.

FIG. 8X is a schematic side elevational view of yet another exampleembodiment of a distal portion of a vascular treatment deviceillustrating an example pattern of radiopaque filaments.

FIG. 8Y is a schematic diagram illustrating an example setup of a braidcarrier mechanism for forming the distal portion of FIG. 8X.

FIG. 8Z is a magnified view of the distal portion of FIG. 8X.

FIG. 9A is a schematic magnified side elevational view of a portion ofanother example embodiment of a distal portion of a vascular treatmentdevice illustrating an example pattern of one or more filaments.

FIG. 9B is a schematic side elevational view of an example embodiment offorming the distal portion of FIG. 9A.

FIG. 9C is a schematic diagram illustrating still another example setupof a braid carrier mechanism for forming the distal portion of FIG. 9B.

FIG. 9D is a schematic diagram illustrating yet another example setup ofa braid carrier mechanism for forming the distal portion of FIG. 9B.

FIG. 9E is a schematic diagram illustrating an example embodiment of amandrel for heat treatment of a distal portion of a vascular treatmentdevice.

FIG. 9F is a schematic diagram illustrating another example embodimentof a mandrel for heat treatment of a distal portion of a vasculartreatment device.

FIG. 10A is a photograph illustrating an example woven tubular structureafter being removed from a mandrel.

FIG. 10B is another photograph illustrating an example woven tubularstructure after being removed from a mandrel.

FIG. 10C is schematic exploded side elevational view of an exampleembodiment of a mandrel.

FIG. 10D is a photograph showing a side elevational view of an exampleembodiment of a mandrel.

FIG. 10E is a schematic side elevational view illustrating an exampleembodiment of a woven tubular structure around a mandrel.

FIG. 10F is a photograph illustrating an example embodiment of a woventubular structure around a mandrel.

FIG. 10G is a schematic side elevational view of another exampleembodiment of a woven tubular structure around a mandrel.

FIG. 10H is a schematic side elevational view of an example embodimentof a woven tubular structure having a transition angle.

FIG. 10I is a schematic side elevational view of another exampleembodiment of a woven tubular structure having a transition angle.

FIG. 10J is a schematic side elevational view of another exampleembodiment of a woven tubular structure around a mandrel.

FIG. 10K is a schematic side elevational view of yet another exampleembodiment of a woven tubular structure around a mandrel.

FIG. 10L is a schematic side elevational view of an example embodimentof removal of a mandrel from within a woven tubular structure.

FIG. 10M is a schematic partial cut away side view of an exampleembodiment of a heat treatment device.

FIG. 11A is a schematic side elevational view of an example embodimentof braiding around a mandrel.

FIG. 11B is a schematic side elevational view of another exampleembodiment of braiding around a mandrel.

FIG. 11C is a schematic side elevational view of an example embodimentof an example embodiment of forming a textile structure.

FIG. 11D is a schematic side elevational view of another exampleembodiment of braiding around of forming a textile structure.

FIG. 11E is perspective view of an example embodiment of a distalportion of a vascular treatment device.

FIG. 12A is a schematic perspective view of an example embodiment of afilament end treatment of a distal portion of a vascular treatmentdevice.

FIG. 12B is a front elevational view of the filament end treatment ofFIG. 12A.

FIG. 12C is a schematic perspective view of another example embodimentof a filament end treatment of a distal portion of a vascular treatmentdevice.

FIG. 12D is a front elevational view of the filament end treatment ofFIG. 12C.

FIG. 12E is a schematic perspective view of yet another exampleembodiment of a filament end treatment of a distal portion of a vasculartreatment device.

FIG. 12F is a schematic perspective view of still another exampleembodiment of a filament end treatment.

FIG. 13A is a photograph illustrating an example embodiment of aplurality of filaments being knitted into an example biomedical textilestructure.

FIG. 13B is a photograph illustrating an example embodiment of aplurality of filaments being woven into another example biomedicaltextile structure.

FIG. 14A is a photograph of an example of a segment of an exampleembodiment of a proximal portion of a vascular treatment device.

FIG. 14B is a photograph of another example segment of an exampleembodiment of a proximal portion of a vascular treatment device.

FIG. 14C is a schematic front elevational view of yet another exampleembodiment of a proximal portion of a vascular treatment device.

FIG. 14D is a schematic side partial cross-sectional view of an exampleembodiment of a balloon catheter.

FIG. 15A is a schematic diagram illustrating an example embodiment of acut pattern.

FIG. 15B is a schematic diagram illustrating an example embodiment of aportion of a cut pattern.

FIG. 15C is a schematic diagram illustrating another example embodimentof a portion of a cut pattern.

FIG. 15D is a schematic diagram illustrating an example embodiment ofstaggered interspersed cut patterns.

FIG. 15E is a schematic diagram illustrating an example embodiment ofstaggered interspersed offset cut patterns.

FIG. 16A is a schematic diagram illustrating an example embodiment of anangled pattern including sharp edges.

FIG. 16B is a schematic diagram illustrating an example embodiment of anangled pattern including rounded edges.

FIG. 16C is a schematic diagram illustrating an example embodiment ofinterspersed offset horizontal patterns including sharp edges.

FIG. 16D is a schematic diagram illustrating an example embodiment ofinterspersed offset horizontal patterns including rounded edges.

FIG. 16E is a schematic diagram illustrating an example embodiment ofslits and stems along the length of an example embodiment of a proximalportion of a vascular treatment device.

FIG. 16F is a schematic diagram illustrating another example embodimentof slits and stems along the length of an example embodiment of aproximal portion of a vascular treatment device.

FIG. 17A is a schematic diagram illustrating an example embodiment of alaser cutting system.

FIG. 17B is a schematic diagram illustrating an example embodiment ofcut design of a slit.

FIG. 17C is a schematic diagram illustrating an example embodiment of aninterspersed offset horizontal pattern including slits and heat impactpuddles.

FIG. 17D is a schematic diagram illustrating another example embodimentof a cut design of a slit.

FIG. 17E is a schematic diagram illustrating yet another exampleembodiment of a cut design of a slit.

FIG. 17F is a schematic diagram illustrating still another exampleembodiment of a cut design of a slit.

FIG. 17G is a schematic diagram illustrating still yet another exampleembodiment of a cut design of a slit.

FIG. 17H is a schematic side elevational view of an example embodimentof a bushing.

FIG. 17I is a schematic cross-sectional front elevational view of thebushing of FIG. 17H along the line 171-171.

FIG. 17J is a schematic side elevational view of an example embodimentof a collet.

FIG. 17K is a schematic cross-sectional front elevational view of thecollet of FIG. 17J along the line 17K-17K.

FIG. 17L is a schematic diagram illustrating an example embodiment of anarrangement of bushings and collets.

FIG. 17M is a schematic diagram illustrating an example embodiment ofthe sag of a hypotube in an arrangement of bushings and collets.

FIG. 17N is a schematic diagram illustrating an example embodiment of awater inlet device.

FIG. 18A is a schematic perspective view of an example embodiment of aproximal portion of a vascular treatment device comprising a pluralityof filaments.

FIG. 18B is a schematic front perspective view of the proximal portionof FIG. 18A.

FIG. 18C is a schematic perspective view of another example embodimentof a proximal portion of a vascular treatment device comprising aplurality of filaments.

FIG. 18D is a schematic side elevational view of an example embodimentof a proximal portion of a vascular treatment device illustrating anexample pattern of radiopaque filaments.

FIG. 18E is a schematic front elevational view of the proximal portionof FIG. 18D.

FIG. 18F is a schematic side elevational view of another exampleembodiment of a proximal portion of a vascular treatment deviceillustrating an example pattern of radiopaque filaments.

FIG. 18G is a schematic front elevational view of the proximal portionof FIG. 18F.

FIG. 18H is a schematic side elevational view of still another exampleembodiment of a proximal portion of a vascular treatment deviceillustrating an example pattern of radiopaque filaments.

FIG. 18I is a schematic front elevational view of the proximal portionof FIG. 18H.

FIG. 18J is a schematic side elevational view of yet another exampleembodiment of a proximal portion of a vascular treatment deviceillustrating an example pattern of radiopaque filaments.

FIG. 18K is a schematic front elevational view of the proximal portionof FIG. 18J.

FIG. 18L is a schematic side elevational view of still yet anotherexample embodiment of a proximal portion of a vascular treatment deviceillustrating an example pattern of radiopaque filaments.

FIG. 18M is a schematic front elevational view of the proximal portionof FIG. 18L.

FIG. 18N is a schematic side elevational view of another exampleembodiment of a proximal portion of a vascular treatment devicecomprising a plurality of filaments.

FIG. 19A is a schematic diagram illustrating an example embodiment ofvariation of slits along the length of an example embodiment of aproximal portion of a vascular treatment device.

FIG. 19B is a schematic diagram illustrating an example embodiment ofvariation of slits and radiopaque markers along the length of an exampleembodiment of a proximal portion of a vascular treatment device.

FIG. 19C is a schematic diagram illustrating still another exampleembodiment of a proximal portion of a vascular treatment device.

FIG. 19D is a schematic partial cut away side view of another exampleembodiment of a heat treatment device.

FIG. 19E is a schematic partial cut away side view of a portion of theheat treatment device of FIG. 19D.

FIG. 19F is a schematic diagram illustrating still yet another exampleembodiment of a proximal portion of a vascular treatment device.

FIG. 20A is a schematic diagram illustrating an example embodiment of ajoint between a proximal portion and a distal portion.

FIG. 20B is a schematic cross-section of the joint of FIG. 20A along theline 20B-20B.

FIG. 20C is a schematic cross-section illustrating and exampleembodiment of filament area in comparison to tube area.

FIGS. 20D-20F schematically illustrate a method of coupling a braidedtube to a hypotube.

FIG. 21A is a schematic diagram illustrating another example embodimentof a joint between a proximal portion and a distal portion.

FIG. 21B is a schematic cross-section of the joint of FIG. 21A along theline 21B-21B.

FIG. 21C is a photograph illustrating the inlay bonding approach of FIG.21.

FIG. 22A is a schematic diagram illustrating yet another exampleembodiment of a joint between a proximal portion and a distal portion.

FIG. 22B is a schematic cross-section of the joint of FIG. 22A along theline 22B-22B.

FIG. 23A is a schematic diagram illustrating still another exampleembodiment of a joint between a proximal portion and a distal portion.

FIG. 23B is a schematic cross-section of the joint of FIG. 23A along theline 23B-23B.

FIG. 23C is a schematic cross-section of the joint 300 of FIG. 23A alongthe line 23C-23C.

FIG. 24A is a schematic diagram illustrating another example embodimentof a joint between a proximal portion and a distal portion.

FIG. 24B is a schematic diagram illustrating yet another exampleembodiment of a joint between a proximal portion and a distal portion.

FIG. 24C is a schematic diagram showing the joints of FIGS. 24A and 24B.

FIG. 24D is a schematic diagram illustrating yet another exampleembodiment of a joint between a proximal portion and a distal portion.

FIG. 25A-1 is a schematic diagram illustrating an example embodiment ofa mechanical detachment system.

FIG. 25A-2 is a schematic diagram illustrating an example embodiment ofthe components of the mechanical detachment system of FIG. 25A-1.

FIG. 25B is a schematic diagram of a partial cross-sectional view of anexample embodiment of a mechanical detachment system.

FIG. 25C is a schematic diagram of a partial cross-sectional view ofanother example embodiment of a mechanical detachment system.

FIG. 25D is a schematic diagram of a partial cross-sectional view of yetanother example embodiment of a mechanical detachment system.

FIG. 25E is a schematic diagram of a partial cross-sectional view ofstill another example embodiment of a mechanical detachment system.

FIG. 26A is a schematic diagram illustrating still another exampleembodiment of a joint between a proximal portion and a distal portion.

FIG. 26B is a schematic diagram illustrating yet still another exampleembodiment of a joint between a proximal portion and a distal portion.

FIG. 26C is a schematic diagram illustrating another example embodimentof a joint between a proximal portion and a distal portion.

FIG. 27A is a schematic diagram of a guide catheter proximal to a clotin vasculature.

FIG. 27B is a schematic diagram of a microwire distal to a clot invasculature and a microcatheter over the microwire.

FIG. 27C is an expanded view of FIG. 27B in the area of the clot.

FIG. 27D is a schematic diagram of a microcatheter distal to a clot invasculature.

FIG. 27E is a schematic diagram illustrating an example embodiment ofthe distal portion of a vascular treatment device being introduced intothe hub of a microcatheter through an introducer sheath.

FIG. 27F is a schematic partial cross-sectional view of an exampleembodiment of a distal portion of a vascular treatment device within anintroducer sheath.

FIG. 27G is a schematic diagram of part of a distal portion of avascular treatment device being deployed distal to a clot invasculature.

FIG. 27H is a schematic diagram of a distal portion of a vasculartreatment device being deployed across a clot in vasculature.

FIG. 27I-1 is a schematic diagram illustrating an example embodiment ofthe distal portion of a vascular treatment device being used inconjunction with thrombus aspiration.

FIG. 27I-2 is a table schematically illustrating an example embodimentof crescendo suction patterns for aspiration.

FIG. 27J is a schematic diagram of a distal portion of a vasculartreatment device illustrating longitudinal bunching of filaments duringdeployment.

FIG. 27K is a schematic diagram of a distal portion of a vasculartreatment device being torsionally rasped.

FIG. 27L is a schematic diagram illustrating an example embodiment of atwo-way shape memory effect of a distal portion of a vascular treatmentdevice.

FIG. 27M is a schematic diagram illustrating the retraction of a distalportion of a vascular treatment device and a clot.

FIG. 27N illustrates an example embodiment of a comparison of a clotlength to a ruler.

FIG. 27O is a schematic diagram of a distal portion of a thrombectomydevice acting as a filter device.

FIG. 27P is a schematic diagram illustrating an example embodiment of atwo-way shape memory effect of the proximal portion of a thrombectomydevice.

FIG. 28A is a schematic diagram of a guide catheter proximal to ananeurysm in vasculature.

FIGS. 28B and 28C are schematic diagrams of a microwire distal to ananeurysm in vasculature and a microcatheter over the microwire.

FIG. 28D is a schematic diagram of a microcatheter distal to an aneurysmin vasculature.

FIG. 28E is a schematic diagram of an example embodiment of the distalportion of a vascular treatment device being deployed distal to ananeurysm in vasculature.

FIG. 28F is a schematic diagram of an example embodiment of the distalportion of a vascular treatment device being deployed across an aneurysmin vasculature.

FIG. 28G is a schematic diagram of an example embodiment of the distalportion of FIG. 6G deployed across an aneurysm in vasculature.

FIG. 28H is a schematic diagram of an example embodiment of the distalportion of FIG. 7B deployed across an aneurysm in vasculature.

FIG. 28I is a schematic diagram of an example embodiment of the distalportion of FIG. 6A deployed across an aneurysm in vasculature.

FIG. 28J is a schematic diagram of an example embodiment of the distalportion of FIG. 6B deployed across an aneurysm in vasculature.

FIG. 28K is a schematic diagram of an example embodiment of the distalportion of FIG. 6C deployed across an aneurysm in vasculature.

FIG. 28L is a schematic diagram of an example embodiment of the distalportion of FIG. 6D deployed across aneurysms in vasculature.

FIG. 28M is a schematic diagram of an example embodiment of the distalportion of FIG. 6E deployed across an aneurysm in vasculature.

FIG. 28N is a schematic diagram of an example embodiment of the distalportion of FIG. 6F deployed across an aneurysm in vasculature.

FIG. 28O is a schematic diagram of an example embodiment of the distalportion of FIG. 7A deployed across a bifurcation aneurysm invasculature.

FIG. 28P is a schematic diagram of an example embodiment of the distalportion of FIG. 6H deployed across a side-wall aneurysm in vasculature.

FIG. 28Q is a schematic diagram of an example embodiment of the distalportion of FIG. 6J deployed across a vascular malformation invasculature.

FIG. 29A is a schematic diagram of an example embodiment of the distalportion of FIG. 7C deployed across a fistula.

FIG. 29B is a schematic diagram of an example embodiment of the distalportion of FIG. 7D deployed in a cardiac wall aneurysm.

FIG. 29C is a schematic diagram of an example embodiment of the distalportion of FIG. 7E deployed in the left atrial appendage of the heart.

DETAILED DESCRIPTION

FIG. 1A is a schematic side elevational view of an example embodiment ofa vascular treatment device 10. The device 10 includes a distal portion100, a proximal portion 200, and a joint 300 coupling the distal portion100 to the proximal portion 200. In the device 10, the joint 300 couplesa proximal segment of the distal portion 100 to a distal segment of theproximal portion 200.

FIG. 1B is a schematic side elevational view of another exampleembodiment of a vascular treatment device 20. The device 20 includes adistal portion 100, a proximal portion 200, and a joint 300 coupling thedistal portion 100 to the proximal portion 200. In the device 20, thejoint 300 couples a distal segment of the distal portion 100 to a distalsegment of the proximal portion 200. The proximal portion 200 extendsthrough the distal portion 100.

FIG. 1C is a schematic side elevational view of yet another exampleembodiment of a vascular treatment device 30. The device 30 includes adistal portion 100, a proximal portion 200, and a joint 300 coupling thedistal portion 100 to the proximal portion 200. In the device 30, thejoint 300 couples a segment between the proximal end and distal the endof the distal portion 100 to a distal segment of the proximal portion200. The proximal portion 200 partially extends through the distalportion 100.

FIG. 1D is a schematic side elevational view of still another exampleembodiment of a vascular treatment device 40. The device 40 includes adistal portion 100, a proximal portion 200, and a joint 300 coupling thedistal portion 100 to the proximal portion 200. In the device 40, thejoint 300 couples the distal portion 100 to a segment of the proximalportion 200 that is proximal to the distal end of the proximal portion200. The distal end of the proximal portion 200 extends beyond thedistal end of the distal portion 100.

For each of the devices 10, 20, 30, 40, a wide variety of distalportions 100, proximal portions 200, and joints 300 are possible,including the distal portions 100, proximal portions 200, and joints 300described herein. In some embodiments, the distal portion 100 includes aplurality of woven bulbs spaced longitudinally apart by woven necks. Insome embodiments, the proximal portion 200 includes a cut hypotubehaving variable longitudinal flexibility. Other varieties of distalportions 100 and proximal portions 200 are also possible. In someembodiments, the distal portion 100 comprises a shape-set textilestructure, the proximal portion 200 comprises a delivery system orhypotube, and the joint 300 comprises a bonding zone in a marker bandregion. In some embodiments, coupling the distal portion 100 and theproximal portion 200 at the joint 300 may be fixed or reversible.

In some embodiments, the distal portion 100 in a radially-collapsedconfiguration has an outer diameter of about 0.0125 inches (approx.0.317 mm) or less and in a radially-expanded configuration has varyingdiameters. In some embodiments, the distal portion 100 in theradially-collapsed configuration has a diameter in the range of about0.1 mm to about 0.9 mm (e.g., about 0.25 mm to about 0.5 mm). In someembodiments, the distal portion 100 in the radially-expandedconfiguration has a diameter in the range of about 1 mm to about 6.5 mm(e.g., about 3 mm to about 4.5 mm). In some embodiments, for exampleembodiments in which the distal portion 100 is configured or intendedfor use in larger vessels or bodily conduits, the distal portion 100 inthe radially-expanded configuration has a diameter in the range of about5 mm to about 40 mm and a diameter in the radially-collapsedconfiguration in the range of about 0.5 mm to about 5 mm. In someembodiments, the ratio of the diameter of the distal portion 100 in theradially-expanded configuration to the diameter of the distal portion100 in the radially-collapsed configuration is about 1.2:1 to about100:1 (e.g., about 1.2:1 to about 20:1, about 9:1 to about 15:1).

FIG. 2A is a schematic side elevational view of an example embodiment ofa distal portion 1000 of a vascular treatment device, for example thedistal portion 100 of the device 10, 20, 30, or 40. The distal portion1000 includes a plurality of woven bulbs 1010 and woven necks 1020. Thedistal portion 1000 includes a woven neck 65 at the distal end. Aradiopaque marker band 25 is coupled to the distal end of the proximalportion 200, discussed in further detail herein. The bulbs 1010 arelongitudinally spaced from each other by the woven necks 1020. In someembodiments, the bulbs 1010 and the necks 1020 are an integral textilestructure in which the filaments that form the bulbs 1010 are the sameas and longitudinally continuous with the filaments that form the necks1020. The bulbs 1010 are generally spherical or spheroid, although theproximal and distal ends of the bulbs 1010 may begin to form the necks1020. The bulbs 1010 extend radially outward from the longitudinal axis,increasing in diameter from proximal to distal, reaching an intermediatepoint, and then decreasing in diameter from proximal to distal. Thenecks 1020 are cylindrical or generally cylindrical along thelongitudinal axis, although the ends of the necks 1020 may flareoutwardly to begin to form the bulbs 1010. The bulbs 1010 in FIG. 2Ahave substantially uniform dimensions or diameters (e.g., within about±5%, about ±10%, about ±15%, or about 20% of each other) such that thedistal portion 1000 may be considered non-tapered or cylindrical.

FIG. 2B is a schematic side elevational view of another exampleembodiment of a distal portion 1100 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. FIG. 2Cis a perspective view of the distal portion 1100 of FIG. 2B. FIG. 2D isa photograph illustrating the distal portion 1100 of FIG. 2B. The distalportion 1100 includes a plurality of woven bulbs 1110 and woven necks1120. The distal portion 1100 includes a woven neck 65 at the distalend. A radiopaque marker band 25 is coupled to the distal end of theproximal portion 200, discussed in further detail herein. The bulbs 1110are longitudinally spaced from each other by the woven necks 1120. Insome embodiments, the bulbs 1110 and the necks 1120 are an integraltextile structure in which the filaments that form the bulbs 1110 arethe same as and longitudinally continuous with the filaments that formthe necks 1120. The bulbs 1110 are generally spherical or spheroid,although the proximal and distal ends of the bulbs 1110 may begin toform the necks 1120. The bulbs 1110 extend radially outward from thelongitudinal axis, increasing in diameter from proximal to distal,reaching an intermediate point, and then decreasing in diameter fromproximal to distal. The necks 1120 are cylindrical or generallycylindrical along the longitudinal axis, although the ends of the necks1120 may flare outwardly to begin to from the bulbs 1110.

The distal portion 1100 includes ten bulbs 1110: three bulbs 1112, threebulbs 1114, two bulbs 1116, and two bulbs 1118. The bulbs 1112 have asmaller diameter than the bulbs 1114, which have a smaller diameter thanthe bulbs 1116, which have a smaller diameter than the bulbs 1118. Thebulbs 1112 have substantially uniform diameters, the bulbs 1114 havesubstantially uniform diameters, the bulbs 1116 have substantiallyuniform diameters, and the bulbs 1118 have substantially uniformdiameters. Due to the differing diameters of the bulbs 1110, the distalportion 1100 may be considered tapered, for example inwardly taperedfrom proximal to distal or outwardly tapered from distal to proximal, orthe distal portion 1100 may be considered stepped, for example inwardlystepped from proximal to distal or outwardly stepped from distal toproximal. Other and opposite configurations are also possible. Forexample, the bulbs 1110 may be inwardly tapered or stepped from distalto proximal or outwardly stepped from proximal to distal. For anotherexample, the bulbs 1110 may have random (e.g., non-sequential) diametersalong the length of the distal portion 1100, which may include sectionsthat are substantially cylindrical and/or sections that are stepped ortapered distally and/or proximally.

In some embodiments, the outer diameters of the bulbs 1110 in theradially-expanded configuration are as follows: the three distalextra-small spherical bulbs 1112 have an outer diameter configured to beoversized to the extra-small vessel segments such as the M2 segments ofthe middle cerebral artery (e.g., about 1.5 mm to about 2.25 mm); theproximally-next three small spherical bulbs 1114 have an outer diameterconfigured to be oversized to the smaller vessel segments such as thedistal M1 segment of the middle cerebral artery (e.g., about 2.25 mm toabout 2.75 mm); the proximally-next two medium spherical bulbs 1116 havean outer diameter configured to be oversized to the medium vesselsegments such as the proximal M1 segment of the middle cerebral artery(e.g., about 2.75 mm to about 3.25 mm); and the proximal two largespherical bulbs 1118 have an outer diameter configured to be oversizedto the large vessel segments such as the distal supra-clinoid segment ofthe internal carotid artery (e.g., about 3.25 mm to about 4 mm). Atapered configuration of the distal portion 1100 can allow for adequateand safe deployment of the distal portion 1100 across blood vessels withmultiple and/or varying diameters (e.g., vasculature that progressivelyreduces in size). Although some example diameters are provided herein,some embodiments of the distal portion 1100 may include diameters of thebulbs 1112, 1114, 1116, 1118 in accordance with the values providedabove and/or diameters that are within about ±5%, about ±10%, about±15%, or about ±20% of any such values.

FIGS. 2A-2D show example embodiments of a pattern of bulb shapes inwhich the bulbs 1010 in FIG. 2A and the bulbs 1110 in FIGS. 2B-2D havesubstantially the same shape. With reference to FIGS. 2B-2D, thissubstantially same shape pattern persists even when the bulbs 1110 havedifferent sizes. In the embodiments illustrated in FIGS. 2A-2D, thebulbs 1010, 1110 are each spherical, but distal portions 100 includingbulbs having other shapes that are substantially the same (e.g., oblong)are also possible.

FIG. 3A is a schematic side elevational view of another exampleembodiment of a distal portion 1200 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 1200 includes a plurality of woven bulbs 1210 and wovennecks 1220. The distal portion 1200 includes a woven neck 65 at thedistal end. A radiopaque marker band 25 is coupled to the distal end ofthe proximal portion 200, discussed in further detail herein. The bulbs1210 are longitudinally spaced from each other by the woven necks 1220.In some embodiments, the bulbs 1210 and the necks 1220 are an integraltextile structure in which the filaments that form the bulbs 1210 arethe same as and longitudinally continuous with the filaments that formthe necks 1220. The bulbs 1210 are generally oblong, although theproximal and distal ends of the bulbs 1210 may begin to form the necks1220. The bulbs 1210 extend radially outward from the longitudinal axis,increasing in diameter from proximal to distal, reaching an intermediatepoint, staying at the intermediate diameter for some length, and thendecreasing in diameter from proximal to distal. The necks 1220 arecylindrical or generally cylindrical along the longitudinal axis,although the ends of the necks 1220 may flare outwardly to begin to fromthe bulbs 1210. The bulbs 1210 in FIG. 3A have substantially uniformdimensions or diameters (e.g., within about ±5%, about ±10%, about ±15%,or about 20% of each other) such that the distal portion 1200 may beconsidered non-tapered or cylindrical.

FIG. 3B is a schematic side elevational view of another exampleembodiment of a distal portion 1300 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. FIG. 3Cis a perspective view of the distal portion 1300 of FIG. 3B. The distalportion 1300 includes a plurality of woven bulbs 1310 and woven necks1320. The distal portion 1300 includes a woven neck 65 at the distalend. A radiopaque marker band 25 is coupled to the distal end of theproximal portion 200, discussed in further detail herein. The bulbs 1310are longitudinally spaced from each other by the woven necks 1320. Insome embodiments, the bulbs 1310 and the necks 1320 are an integraltextile structure in which the filaments that form the bulbs 1310 arethe same as and longitudinally continuous with the filaments that formthe necks 1320. The bulbs 1310 are generally oblong, although theproximal and distal ends of the bulbs 1310 may begin to form the necks1320. The bulbs 1310 extend radially outward from the longitudinal axis,increasing in diameter from proximal to distal, reaching an intermediatepoint, staying at the intermediate diameter for some length, and thendecreasing in diameter from proximal to distal. The necks 1320 arecylindrical or generally cylindrical along the longitudinal axis,although the ends of the necks 1320 may flare outwardly to begin to fromthe bulbs 1310.

The distal portion 1300 includes ten bulbs 1310: three bulbs 1312, threebulbs 1314, two bulbs 1316, and two bulbs 1318. The bulbs 1312 have asmaller diameter than the bulbs 1314, which have a smaller diameter thanthe bulbs 1316, which have a smaller diameter than the bulbs 1318. Thebulbs 1312 have substantially uniform diameters, the bulbs 1314 havesubstantially uniform diameters, the bulbs 1316 have substantiallyuniform diameters, and the bulbs 1318 have substantially uniformdiameters. Due to the differing diameters of the bulbs 1310, the distalportion 1300 may be considered tapered, for example inwardly taperedfrom proximal to distal or outwardly tapered from distal to proximal, orthe distal portion 1300 may be considered stepped, for example inwardlystepped from proximal to distal or outwardly stepped from distal toproximal. Other and opposite configurations are also possible. Forexample, the bulbs 1310 may be inwardly tapered or stepped from distalto proximal or outwardly stepped from proximal to distal. For anotherexample, the bulbs 1310 may have random (e.g., non-sequential) diametersalong the length of the distal portion 1300, which may include sectionsthat are substantially cylindrical and/or sections that are stepped ortapered distally and/or proximally.

In some embodiments, the outer diameters of the bulbs 1310 in theradially-expanded configuration are as follows: the three distalextra-small oblong bulbs 1312 have an outer diameter configured to beoversized to the extra-small vessel segments such as the M2 segments ofthe middle cerebral artery (e.g., about 1.5 mm to about 2.25 mm); theproximally-next three small oblong bulbs 1314 have an outer diameterconfigured to be oversized to the smaller vessel segments such as thedistal M1 segment of the middle cerebral artery (e.g., about 2.25 mm toabout 2.75); the proximally-next two medium oblong bulbs 1316 have anouter diameter configured to be oversized to the medium vessel segmentssuch as the proximal M1 segment of the middle cerebral artery (e.g.,about 2.75 mm to about 3.25 mm); and the proximal two large oblong bulbs1318 have an outer diameter configured to be oversized to the largevessel segments such as the distal supra-clinoid segment of the internalcarotid artery (e.g., about 3.25 mm to about 4 mm). A taperedconfiguration of the distal portion 1300 can allow for adequate and safedeployment of the distal portion 1300 across blood vessels with multipleand/or varying diameters (e.g., vasculature that progressively reducesin size). Although some example diameters are provided herein, someembodiments of the distal portion 1300 may include diameters of thebulbs 1312, 1314, 1316, 1318 in accordance with the values providedabove and/or diameters that are without about ±5%, about ±10%, about±15%, or about ±20% of any such values.

FIG. 4A is a schematic side elevational view of another exampleembodiment of a distal portion 1400 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 1400 includes a plurality of woven bulbs 1410 and wovennecks 1420. The distal portion 1400 includes a woven neck 65 at thedistal end. A radiopaque marker band 25 is coupled to the distal end ofthe proximal portion 200, discussed in further detail herein. The bulbs1410 are longitudinally spaced from each other by the woven necks 1420.In some embodiments, the bulbs 1410 and the necks 1420 are an integraltextile structure in which the filaments that form the bulbs 1410 arethe same as and longitudinally continuous with the filaments that formthe necks 1420. The necks 1420 are cylindrical or generally cylindricalalong the longitudinal axis, although the ends of the necks 1420 mayflare outwardly to begin to from the bulbs 1410. The bulbs 1410 in FIG.4A have substantially uniform diameters such that the distal portion1400 may be considered non-tapered or cylindrical.

The distal portion 1400 includes ten bulbs 1410: seven generallyspherical bulbs 1412 and three generally oblong bulbs 1414, in aninterspersed pattern, from distal to proximal, of two bulbs 1412, onebulb 1414, two bulbs 1412, one bulb 1414, two bulbs 1412, one bulb 1414,and one bulb 1412. Other interspersing patterns are also possible. Forexample, an interspersed pattern may include one bulb 1412, one bulb1414, one bulb 1412, one bulb 1414, one bulb 1412, one bulb 1414, onebulb 1412, one bulb 1414, one bulb 1412, and one bulb 1414. For anotherexample, interspersed pattern may include one bulb 1412, two bulbs 1414,one bulb 1412, two bulbs 1414, one bulb 1412, two bulbs 1414, and onebulb 1412.

FIG. 4B is a schematic side elevational view of another exampleembodiment of a distal portion 1500 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thebulbs 1510 are longitudinally spaced from each other by the woven necks1520. The distal portion 1500 includes a woven neck 65 at the distalend. A radiopaque marker band 25 is coupled to the distal end of theproximal portion 200, discussed in further detail herein. In someembodiments, the bulbs 1510 and the necks 1520 are an integral textilestructure in which the filaments that form the bulbs 1510 are the sameas and longitudinally continuous with the filaments that form the necks1520. The necks 1520 are cylindrical or generally cylindrical along thelongitudinal axis, although the ends of the necks 1520 may flareoutwardly to begin to from the bulbs 1510.

The distal portion 1500 includes ten bulbs 1510: six generally sphericalbulbs 1511 and four generally oblong bulbs 1531. The generally sphericalbulbs 1511 include two bulbs 1512, two bulbs 1514, one bulb 1516, andone bulb 1518. The bulbs 1512 have a smaller diameter than the bulbs1514, which have a smaller diameter than the bulb 1516, which has asmaller diameter than the bulb 1518. The bulbs 1512 have substantiallyuniform diameters and the bulbs 1514 have substantially uniformdiameters. The generally oblong bulbs 1531 include one bulb 1532, onebulb 1534, one bulb 1536, and one bulb 1538. The bulb 1532 has a smallerdiameter than the bulb 1534, which has a smaller diameter than the bulb1536, which has a smaller diameter than the bulb 1538. Due to thediffering diameters of the bulbs 1510, the distal portion 1500 may beconsidered tapered, for example inwardly tapered from proximal to distalor outwardly tapered from distal to proximal, or the distal portion 1500may be considered stepped, for example inwardly stepped from proximal todistal or outwardly stepped from distal to proximal. Other and oppositeconfigurations are also possible. For example, the bulbs 1510 may beinwardly tapered or stepped from distal to proximal or outwardly steppedfrom proximal to distal. For another example, the bulbs 1510 may haverandom (e.g., non-sequential) diameters along the length of the distalportion 1500, which may include sections that are substantiallycylindrical and/or sections that are stepped or tapered distally and/orproximally.

In some embodiments, the outer diameters of the bulbs 1510 in theradially-expanded configuration are as follows: the two distalextra-small spherical bulbs 1512 and the distal extra-small oblong bulb1532 have an outer diameter configured to be oversized to theextra-small vessel segments such as the M2 segments of the middlecerebral artery (e.g., about 1.5 mm to about 2.25 mm); theproximally-next two small spherical bulbs 1514 and the small oblong bulb1534 have an outer diameter configured to be oversized to the smallervessel segments such as the distal M1 segment of the middle cerebralartery (e.g., about 2.25 mm to about 2.75 mm); the proximally-nextmedium spherical bulb 1516 and the medium oblong bulb 1536 have an outerdiameter configured to be oversized to the medium vessel segments suchas the proximal M1 segment of the middle cerebral artery (e.g., about2.75 mm to about 3.25 mm); and the proximally-next large spherical bulb1518 and the large oblong bulb 1538 have an outer diameter configured tobe oversized to the large vessel segments such as the distalsupra-clinoid segment of the internal carotid artery (e.g., about 3.25mm to about 4 mm). A tapered configuration of the distal portion 1500can allow for adequate and safe deployment of the distal portion 1500across blood vessels with multiple and/or varying diameters (e.g.,vasculature that progressively reduces in size). Although some examplediameters are provided herein, some embodiments of the distal portion1500 may include diameters of the bulbs 1512, 1514, 1516, 1518, 1532,1534, 1536, 1538 in accordance with the values provided above and/ordiameters that are within about ±5%, about ±10%, about ±15%, or about±20% of any such values.

The distal portion 1500 includes ten bulbs 1510: six generally sphericalbulbs 1511 and four generally oblong bulbs 1531, in an interspersedpattern. Other interspersing patterns are also possible. For example, aninterspersed pattern may include one bulb 1512, one bulb 1532, two bulbs1514, one bulb 1534, two bulbs 1516, one bulb 1536, one bulb 1518, andone bulb 1538. For another example, interspersed pattern may include onebulb 1512, two bulbs 1532, two bulbs 1514, one bulb 1534, one bulb 1516,one bulb 1536, one bulb 1518, and one bulb 1538.

FIG. 4C is a schematic side elevational view of another exampleembodiment of a distal portion 2200 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. FIG. 4Dis a schematic proximal end view of the distal portion 2200 shown inFIG. 4C. The distal portion 2200 includes a plurality of woven bulbs2210 and woven necks 2220 including filaments 156. The bulbs 2210 arelongitudinally spaced from each other by the woven necks 2220. In someembodiments, the bulbs 2210 and the necks 2220 are an integral textilestructure in which the filaments that form the bulbs 2210 are the sameas and longitudinally continuous with the filaments that form the necks2220. The bulbs 2210 are generally spherical, although the proximal anddistal ends of the bulbs 2210 may begin to form the necks 2220. Thenecks 2220 are aligned along a longitudinal axis 2230. The bulbs 2210are aligned along a longitudinal axis 2240. The longitudinal axis 2240may run through a center of the distal portion 2200. The longitudinalaxis 2230 is radially offset from the longitudinal axis 2240. The necks2220 are aligned with chords of the bulbs 2210. The necks 2220 arecylindrical or generally cylindrical along the central or longitudinalaxis, although the ends of the necks 2220 may flare outwardly to beginto from the bulbs 2210. The bulbs 2210 in FIG. 4C have substantiallyuniform dimensions or diameters (e.g., within about ±5%, about ±10%,about ±15%, or about 20% of each other) such that the distal portion2200 may be considered non-tapered or cylindrical.

FIG. 4E is a schematic side elevational view of yet another exampleembodiment of a distal portion 2400 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30 or 40. FIG. 4Fis a schematic proximal end view of the distal portion 2400 of FIG. 4E.The distal portion 2400 includes a plurality of woven bulbs 2410, 2415and woven necks 2420. The bulbs 2410, 2415 are longitudinally spacedfrom each other by the woven necks 2420. In some embodiments, the bulbs2410, 2415 and the necks 2420 are an integral textile structure in whichthe filaments 156 that form the bulbs 2410, 2415 are the same as andlongitudinally continuous with the filaments 156 that form the necks2420. The bulbs 2410, 2415 are generally spherical, although theproximal and distal ends of the bulbs 2410, 2415 may begin to form thenecks 2420. The necks 2220 are aligned along a longitudinal axis 2430.The longitudinal axis 2430 may run through a center of the distalportion 2400. The longitudinal axis 2430 is aligned to the chords ofbulbs 2410 and to the chords of the bulbs 2415. The chords through theeach of the bulbs 2410 are the same. The chords through each of thebulbs 2415 are the same. The chords through the bulbs 2410 are differentfrom the chords through the bulbs 2415. The longitudinal position of thebulbs 2410, 2415 may alternate. The necks 2420 are between differentchords of the bulbs 2410, 2415. The necks 2420 are cylindrical orgenerally cylindrical along the central or longitudinal axis, althoughthe ends of the necks 2420 may flare outwardly to begin to from thebulbs 2410, 2415. The bulbs 2410 in FIG. 4E have substantially uniformdimensions or diameters (e.g., within about ±5%, about ±10%, about ±15%,or about 20% of each other) such that the distal portion 2400 may beconsidered non-tapered or cylindrical.

FIG. 4G is a schematic side elevational view of yet another exampleembodiment of a distal portion 2500 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. FIG. 4His a schematic proximal end view of the distal portion 2500 of FIG. 4G.The distal portion 2500 includes a plurality of woven bulbs 2510 alongan elongate support structure 2520 (such as a neck, tube, spindle,spine, rod, backbone, etc.). The elongate support structure 2520 isaligned along a longitudinal axis 2530. The longitudinal axis 2530 mayrun through a center of the distal portion 2500. The bulbs 2510 arehemi-spherical or generally hemi-spherical along the longitudinal axis2530, although the elongate support structure 2520 between the bulbs2510 may flare outwardly to begin to from the bulbs 2510. In someembodiments, the bulbs 2510 are hemispherical or generallyhemi-spherical and so they appear as bulges on the sides of a singleelongate support structure 2520 rather than as bulbs separated by aplurality of necks. The bulbs 2510 have substantially uniform dimensionsor diameters (e.g., within about ±5%, about ±10%, about ±15%, or about20% of each other) such that the distal portion 2500 may be considerednon-tapered.

The distal portion 2500 includes bulbs 2510 that are phase-shifted. Thebulbs 2510 are phase-shifted from each other by a phase-shift angle ofabout 120° relative to the longitudinal axis 2530 (for e.g., the bulbs2516, 2512, 2519, 2515 are phase-shifted from the bulbs 2511, 2518, 2514by a phase-shift angle 2560 of about 120°; the bulbs 2511, 2518, 2514are phase-shifted from the bulbs 2517, 2513, 2521 by a phase-shift angle2540 of about 120°; and the bulbs 2517, 2513, 2521 are phase-shiftedfrom the bulbs 2516, 2512, 2519, 2515 by a phase-shift angle 2550 ofabout 120°). A phase-shifted configuration of the bulbs 2510 in thedistal portion 2500 can allow for effective torsional rasping andmechanical thrombectomy of hard clots or organized thrombus adherent tothe endothelium wall (inner walls of blood vessels). The term thrombus,as used herein, shall be given its ordinary meaning and shall include,but not be limited to, blood clots (e.g., attached to the blood vessel),emboli (e.g., floating blood clots), and other debris that may beremoved from vessels. The terms thrombus, clot, and embolus may be usedinterchangeably depending on context. Although some example phase-shiftangles are provided herein, some embodiments of the distal portion 2500may include symmetric phase-shift angles that are uniform to each otherwith values that range between about 15° and about 345° (e.g., thephase-shift angles 2540, 2550, 2560 each being about 120°). For anotherexample, some embodiments of the distal portion 2500 may includeasymmetric phase-shift angles that are varying to each other with valuesthat range between about 15° and about 345° (e.g., the phaseshift-angles 2540, 2550 both being about 80° and the phase-shift angle2560 being about 200°).

FIG. 4I is a schematic side elevational view of another exampleembodiment of a distal portion 1900 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 1900 includes a plurality of woven bulbs 1910 and wovennecks 1920. The distal portion 1900 includes a woven neck 65 at thedistal end. The necks 1920 are cylindrical or generally cylindricalalong the longitudinal axis, although the ends of the necks 1920 mayflare outwardly to begin to from the bulbs 1910.

The distal portion 1900 includes seven bulbs 1910: two bulbs 1911, twobulbs 1913, one bulb 1915, and two bulbs 1917. The bulbs 1911 have asmaller diameter than the bulbs 1913, which have a smaller diameter thanthe bulb 1915, which has a smaller diameter than the bulbs 1917. Thebulbs 1911 have substantially uniform diameters, the bulbs 1913 havesubstantially uniform diameters, and the bulbs 1917 have substantiallyuniform diameters.

In some embodiments, the outer diameters of the bulbs 1910 in theradially-expanded configuration are as follows: the two distalextra-small spherical bulbs 1911 have an outer diameter configured to beoversized to the extra-small vessel segments such as the M2 segments ofthe middle cerebral artery (e.g., about 1.5 mm to about 2.25 mm); theproximally-next two small spherical bulbs 1913 have an outer diameterconfigured to be oversized to the smaller vessel segments such as thedistal M1 segment of the middle cerebral artery (e.g., about 2.25 mm toabout 2.75 mm); the proximally-next medium spherical bulb 1915 has anouter diameter configured to be oversized to the medium vessel segmentssuch as the proximal M1 segment of the middle cerebral artery (e.g.,about 2.75 mm to about 3.25 mm); and the proximally-next large sphericalbulbs 1917 have an outer diameter configured to be oversized to thelarge vessel segments such as the distal supra-clinoid segment of theinternal carotid artery (e.g., about 3.25 mm to about 4 mm). Due to thediffering diameters of the bulbs 1910, the distal portion 1900 may beconsidered tapered, for example inwardly tapered from proximal to distalor outwardly tapered from distal to proximal, or the distal portion 1900may be considered stepped, for example inwardly stepped from proximal todistal or outwardly stepped from distal to proximal. Other and oppositeconfigurations are also possible. For example, the bulbs 1910 may beinwardly tapered or stepped from distal to proximal or outwardly steppedfrom proximal to distal. For another example, the bulbs 1910 may haverandom (e.g., non-sequential) diameters along the length of the distalportion 1900, which may include sections that are substantiallycylindrical and/or sections that are stepped or tapered distally and/orproximally. A tapered configuration of the distal portion 1900 canprovide adequate and safe deployment of the distal portion 1900 acrossblood vessels with multiple and/or varying diameters (e.g., vasculaturethat progressively reduces in size). Although some example diameters areprovided herein, some embodiments of the distal portion 1900 may includediameters of the bulbs 1911, 1913, 1915, 1917 in accordance with thevalues provided above and/or diameters that are within about ±5%, about±10%, about ±15%, or about ±20% of any such values.

The necks 1920 include a first neck 1921 having a first neck diameter1931 (also the distal neck 65), a second neck 1922 having a second neckdiameter 1932, a third neck 1923 having a third neck diameter 1933, afourth neck 1924 having a fourth neck diameter 1934, a fifth neck 1925having a fifth neck diameter 1935, a sixth neck 1926 having a sixth neckdiameter 1936, a seventh neck 1927 having a seventh neck diameter 1937,and an eighth neck 1929 having an eighth neck diameter 1939 (also theproximal neck). The neck diameters 1930 including 1931, 1932, 1933,1934, 1935, 1936, 1937, 1939 are uniform or substantially uniform. Thedistal portion 1900 includes necks 1920 having varying lengths: fournecks 1921, 1922, 1924, 1927 having relatively short lengths, two necks1926, 1929 having relatively medium lengths, and two necks 1923, 1925having relatively long lengths in an interspersed pattern. Otherinterspersing patterns are also possible. For example, an interspersedpattern may include four necks 1921, 1922, 1924, 1927 with relativelyshort lengths, two necks 1926, 1929 with relatively medium lengths, andtwo necks 1923, 1925 with relatively long lengths.

Necks 1921, 1922, 1923, 1924, 1925, 1926, 1927, 1929 having varyinglengths can provide controlled expansion of the bulbs 1910 adjacent tothe necks 1920 during torsional rasping, aid in wall apposition of thebulbs 1910, and/or inhibit or prevent distal emboli. Necks 1921, 1922,1923, 1924, 1925, 1926, 1927, 1929 having varying lengths may bedeployed in such a manner that necks 1920 with longer lengths aredeployed at the region of maximal clot burden, which can provideeffective torsional rasping by entrapping soft clots or non-organizedthrombus between the undulations of the bulbs 1910 on the varyinglengths of the necks 1920.

FIG. 4J is a schematic side elevational view of another exampleembodiment of a distal portion 2000 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 2000 includes a plurality of woven bulbs 2010 and wovennecks 2020. The distal portion 2000 includes a woven neck 65 at thedistal end. The necks 2020 are cylindrical or generally cylindricalalong the longitudinal axis, although the ends of the necks 2020 mayflare outwardly to begin to from the bulbs 2010.

The distal portion 2000 includes nine bulbs 2010: three bulbs 2011, twobulbs 2013, two bulbs 2015, and two bulbs 2017. The bulbs 2011 have asmaller diameter than the bulbs 2013, which have a smaller diameter thanthe bulbs 2015, which have smaller diameters than the bulbs 2017. Thebulbs 2011 have substantially uniform diameters, the bulbs 2013 havesubstantially uniform diameters, the bulbs 2015 have substantiallyuniform diameters, and the bulbs 2017 have substantially uniformdiameters.

In some embodiments, the outer diameters of the bulbs 2010 in theradially-expanded configuration are as follows: the three distalextra-small spherical bulbs 2011 have an outer diameter configured to beoversized to the extra-small vessel segments such as the M2 segments ofthe middle cerebral artery (e.g., about 1.5 mm to about 2.25 mm); theproximally-next two small spherical bulbs 2013 have an outer diameterconfigured to be oversized to the smaller vessel segments such as thedistal M1 segment of the middle cerebral artery (e.g., about 2.25 mm toabout 2.75 mm); the proximally-next two medium spherical bulbs 2015 havean outer diameter configured to be oversized to the medium vesselsegments such as the proximal M1 segment of the middle cerebral artery(e.g., about 2.75 mm to about 3.25 mm); and the proximally-next largespherical bulbs 2017 have an outer diameter configured to be oversizedto the large vessel segments such as the distal supra-clinoid segment ofthe internal carotid artery (e.g., about 3.25 mm to about 4 mm). Due tothe differing diameters of the bulbs 2010, the distal portion 2000 maybe considered tapered, for example inwardly tapered from proximal todistal or outwardly tapered from distal to proximal, or the distalportion 2000 may be considered stepped, for example inwardly steppedfrom proximal to distal or outwardly stepped from distal to proximal.Other and opposite configurations are also possible. For example, thebulbs 2010 may be inwardly tapered or stepped from distal to proximal oroutwardly stepped from proximal to distal. For another example, thebulbs 2010 may have random (e.g., non-sequential) diameters along thelength of the distal portion 2000, which may include sections that aresubstantially cylindrical and/or sections that are stepped or tapereddistally and/or proximally. A tapered configuration of the distalportion 2000 can provide adequate and safe deployment of the distalportion 2000 across blood vessels with multiple and/or varying diameters(e.g., vasculature that progressively reduces in size). Although someexample diameters are provided herein, some embodiments of the distalportion 2000 may include diameters of the bulbs 2011, 2013, 2015, 2017,2019 in accordance with the values provided above and/or diameters thatare within about ±5%, about ±10%, about ±15%, or about ±20% of any suchvalues.

The necks 2020 include a first neck 2021 having a first neck diameter2041 (also the distal neck 65), a second neck 2022 having a second neckdiameter 2031, a third neck 2023 having a third neck diameter 2032, afourth neck 2024 having a fourth neck diameter 2033, a fifth neck 2025having a fifth neck diameter 2034, a sixth neck 2026 having a sixth neckdiameter 2035, a seventh neck 2027 having a seventh neck diameter 2036,and an eighth neck 2028 having an eighth neck diameter 2037, a ninthneck 2029 having a ninth neck diameter 2038, a tenth neck 2040 having atenth neck diameter 2039 (also the proximal neck). The distal portion2000 includes varying neck diameters 2030: seven necks 2021, 2022, 2023,2025, 2026, 2028, 2040 having relatively narrow neck diameters 2041,2031, 2032, 2034, 2035, 2037, 2039, respectively, and three necks 2024,2027, 2029 having relatively wide neck diameters 2033, 2036, 2038,respectively, in an interspersed pattern. Other interspersing patternsare also possible. For example, an interspersed pattern may includeseven necks 2021, 2022, 2023, 2025, 2027, 2029, 2040 having relativelynarrow neck diameters 2041, 2031, 2032, 2034, 2036, 2038, 2039,respectively, and three necks 2024, 2026, 2028 having relatively widerneck diameters 2033, 2035, 2037, respectively (e.g., relatively widerneck diameters between changing bulb diameters). For another example, aninterspersed pattern may include five necks 2021, 2024, 2026, 2028, 2040having relatively narrow neck diameters 2041, 2033, 2035, 2037, 2039,respectively, and five necks 2022, 2023, 2025, 2027, 2029 havingrelatively wider neck diameters 2031, 2032, 2034, 2036, 2038,respectively (e.g., relatively narrow neck diameters between changingbulb diameters).

Varying neck diameters 2031, 2032, 2033, 2034, 2035, 2036, 2037, 2038,2039, 2041 can allow for the outer diameters of the bulbs 2010 and/orthe varying neck diameters 2030 to have adequate wall apposition acrossblood vessels with multiple and/or varying diameters (e.g., vasculaturethat progressively reduces in size), which can inhibit or prevent embolifrom drifting into side branches of blood vessels during torsionalrasping and/or mechanical thrombectomy. Varying neck diameters 2031,2032, 2033, 2034, 2035, 2036, 2037, 2038, 2039, 2041 can allow thedistal portion 2000 to be deployed in such a way that the wider neckdiameters are deployed at the region of bifurcations or higher bloodvessel branches and/or at regions of blood vessel diameter transitions,which can allow the distal portion 2000 to serve as a filter to inhibitemboli from drifting into the branches of the blood vessels duringtorsional rasping and/or mechanical thrombectomy.

FIG. 4K is a schematic side elevational view of another exampleembodiment of a distal portion 2100 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 2100 includes a plurality of woven bulbs 2110 and wovennecks 2120. The distal portion includes a woven neck 65 at the distalend. The necks 2120 are cylindrical or generally cylindrical along thelongitudinal axis, although the ends of the necks 2120 may flareoutwardly to begin to from the bulbs 2110.

The distal portion 2100 includes nine bulbs 2110: three bulbs 2111, twobulbs 2113, two bulbs 2115, and two bulbs 2117. The bulbs 2111 have asmaller diameter than the bulbs 2113, which have a smaller diameter thanthe bulbs 2115, which have smaller diameters than the bulbs 2117. Thebulbs 2111 have substantially uniform diameters, the bulbs 2113 havesubstantially uniform diameters, the bulbs 2115 have substantiallyuniform diameters, and the bulbs 2117 have substantially uniformdiameters.

In some embodiments, the outer diameters of the bulbs 2110 in theradially-expanded configuration are as follows: the three distalextra-small spherical bulbs 2111 have an outer diameter configured to beoversized to the extra-small vessel segments such as the M2 segments ofthe middle cerebral artery (e.g., about 1.5 mm to about 2.25 mm); theproximally-next two small spherical bulbs 2113 have an outer diameterconfigured to be oversized to the smaller vessel segments such as thedistal M1 segment of the middle cerebral artery (e.g., about 2.25 mm toabout 2.75 mm); the proximally-next medium spherical bulbs 2115 have anouter diameter configured to be oversized to the medium vessel segmentssuch as the proximal M1 segment of the middle cerebral artery (e.g.,about 2.75 mm to about 3.25 mm); and the proximally-next large sphericalbulbs 2117 have an outer diameter configured to be oversized to thelarge vessel segments such as the distal supra-clinoid segment of theinternal carotid artery (e.g., about 3.25 mm to about 4 mm). Due to thediffering diameters of the bulbs 2110, the distal portion 2100 may beconsidered tapered, for example inwardly tapered from proximal to distalor outwardly tapered from distal to proximal, or the distal portion 2100may be considered stepped, for example inwardly stepped from proximal todistal or outwardly stepped from distal to proximal. Other and oppositeconfigurations are also possible. For example, the bulbs 2110 may beinwardly tapered or stepped from distal to proximal or outwardly steppedfrom proximal to distal. For another example, the bulbs 2110 may haverandom (e.g., non-sequential) diameters along the length of the distalportion 2100, which may include sections that are substantiallycylindrical and/or sections that are stepped or tapered distally and/orproximally. A tapered configuration of the distal portion 2100 canprovide adequate and safe deployment of the distal portion 2100 acrossblood vessels with multiple and/or varying diameters (e.g., vasculaturethat progressively reduces in size). Although some example diameters areprovided herein, some embodiments of the distal portion 2100 may includediameters of the bulbs 2111, 2113, 2115, 2117 in accordance with thevalues provided above and/or diameters that are within about ±5%, about±10%, about ±15%, or about ±20% of any such values.

The necks 2120 include a first neck 2121 having a first neck diameter2131 (also the distal neck 65), a second neck 2122 having a second neckdiameter 2132, a third neck 2123 having a third neck diameter 2133, afourth neck 2124 having a fourth neck diameter 2134, a fifth neck 2125having a fifth neck diameter 2135, a sixth neck 2126 having a sixth neckdiameter 2136, a seventh neck 2127 having a seventh neck diameter 2137,an eighth neck 2128 having an eighth neck diameter 2138, a ninth neck2129 having a ninth neck diameter 2129, a tenth neck 2145 having a tenthneck diameter 2141 (also the proximal neck). The necks 2120 have varyingneck diameters 2130 and varying lengths.

The distal portion 2100 includes varying neck diameters 2130: sevennecks 2121, 2122, 2123, 2125, 2126, 2128, 2145 having relatively narrowneck diameters 2131, 2132, 2133, 2135, 2136, 2138, 2141, respectively,and three necks 2124, 2127, 2129 having relatively wide neck diameters2134, 2137, 2139, respectively, in an interspersed pattern. Otherinterspersing patterns are also possible. For example, an interspersedpattern may include seven necks 2121, 2122, 2123, 2125, 2127, 2129, 2145having relatively narrow neck diameters 2131, 2132, 2133, 2135, 2137,2139, 2141, respectively, and three necks 2124, 2126, 2128 havingrelatively wider neck diameters 2134, 2136, 2138, respectively (e.g.,relatively wider neck diameters between changing bulb diameters). Foranother example, an interspersed pattern may include five necks 2121,2124, 2126, 2128, 2145 having relatively narrow neck diameters 2131,2134, 2136, 2138, 2141, respectively, and five necks 2122, 2123, 2125,2127, 2129 having relatively wider neck diameters 2132, 2133, 2135,2137, 2139, respectively (e.g., relatively narrow neck diameters betweenchanging bulb diameters).

The distal portion 2100 includes necks 2120 having varying lengths:eight necks 2121, 2122, 2123, 2124, 2126, 2127, 2129, 2145 havingrelatively short lengths, one neck 2128 having a relatively mediumlength, and one neck 2125 having a relatively long length in aninterspersed pattern. Other interspersing patterns are also possible.For example, an interspersed pattern may include four necks 2121, 2122,2123, 2124 having relatively short lengths, four necks 2126, 2127, 2129,2145 having relatively medium lengths, and two necks 2125, 2128 havingrelatively large lengths.

Varying neck diameters 2131, 2132, 2133, 2134, 2135, 2136, 2137, 2138,2139, 2141 can allow for the outer diameters of the bulbs 2110 and/orthe varying neck diameters 2130 to have adequate wall apposition acrossblood vessels with multiple and/or varying diameters (e.g., vasculaturethat progressively reduces in size), which can inhibit or prevent embolifrom drifting into side branches of blood vessels during torsionalrasping and/or mechanical thrombectomy. Varying neck diameters 2130including 2131, 2132, 2133, 2134, 2135, 2136, 2137, 2138, 2139, 2141 canallow the distal portion 2100 to be deployed in such a way that thewider neck diameters are deployed at the region of bifurcations orhigher blood vessel branches and/or at regions of blood vessel diametertransitions, which can allow the distal portion 2100 to serve as afilter to inhibit emboli from drifting into the branches of the bloodvessels during torsional rasping and/or mechanical thrombectomy. Necks2121, 2122, 2123, 2124, 2125, 2126, 2127, 2128, 2129, 2145 havingvarying lengths can provide controlled expansion of the bulbs 2110adjacent to the necks 2120 during torsional rasping, aid in wallapposition of the bulbs 2110, and/or inhibit or prevent distal emboli.Necks 2121, 2122, 2123, 2124, 2125, 2126, 2127, 2128, 2129, 2145 havingvarying lengths may be deployed in such a manner that necks 2120 withlonger lengths are deployed at the region of maximal clot burden, whichcan provide effective torsional rasping by entrapping soft clots ornon-organized thrombus between the undulations of the bulbs 2110 on thevarying lengths of the necks 2120. Necks 2121, 2122, 2123, 2124, 2125,2126, 2127, 2128, 2129, 2145 with varying lengths and/or diameters 2131,2132, 2133, 2134, 2135, 2136, 2137, 2138, 2139, 2141 may provide forcombinations of some or all of these advantages.

As illustrated, for example in FIGS. 2A-4K, and described herein, thedistal portion 100 of the device 10, 20, 30, or 40 may include a widevariety of different bulb parameters such as bulb quantity, shape, size,spacing, phase-shifting with regards to the longitudinal axis or to achord of the axis, filament parameters (e.g., material, material ratio,thickness, shape, etc.), different neck parameters (e.g., neck diameter,neck length, etc.), braid parameters (e.g., pattern, angle, density,pore size, etc.), alignment to the longitudinal axis or to a chord ofthe axis, combinations thereof, and the like.

Each of the distal portions 1000, 1100 illustrated in FIGS. 2A and 2Bincludes ten bulbs 1010, 1110. Other numbers of bulbs 1010, 1110 arealso possible. For example, in some embodiments, the distal portionincludes between one and nine bulbs, between 11 and 30 bulbs, or morethan 30 bulbs. In some embodiments, the distal portion includes 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 bulbs. Insome implementations, for example in which the device is configured tobe used in peripheral vessels (e.g., in the leg), where clots can be upto 20 cm or even 40 cm, 11 to 30 or more, or 40 to 60, bulbs may beused. In some embodiments, 1 bulb is used for about every 0.2 cm to 5 cm(e.g., about every 0.5 cm to 2 cm).

The term bulb, as used herein, shall be given its ordinary meaning andshall include, but not be limited to, protruding or bulging portionsthat may be rounded (e.g., rounded balls, spheres, cylinders, or beads)or non-rounded, which are typically, but not necessarily, provided along(e.g., separately or integrated with) a support structure. A bulb mayhave a consistent cross-section or may have two or more differentcross-sections. A bulb may have one, two, or more than two open ends orlumens therethrough. Bulb shapes may include, for example, e.g., withrespect to a top view, side view, and/or cross-section, at least one ofsphere, oblong, egg, oval, ellipse, cylinder, spiral, twisted, helical,triangle, rectangle, parallelogram, rhombus, square, diamond, pentagon,hexagon, heptagon, octagon, nonagon, decagon, quatrefoil, trapezoid,trapezium, other polygons, oblate spheroids (e.g., flattened spheroids),prolate spheroids (e.g., elongated spheroids), curvilinear or bulgedversions of these and other shapes, combinations thereof (e.g., a distalsection of bulb having a different shape than a proximal section of abulb), and the like. Different shapes of bulbs may be used in a distalportion 100. For example, as illustrated in FIGS. 4A and 4B, sphericalbulbs and oblong bulbs may be used in the same distal portion 100. Insome embodiments, different shapes of bulbs are alternated. In someembodiments, the distal portion 100 includes a series of various shapesof bulbs (e.g., including two or more bulbs each having differentshapes), and each series is repeated two, three, four, five, six, seven,or more times. In some embodiments, the distal portion 100 includesbulbs having a first shape at the ends and bulbs having a seconddifferent shape between the end bulbs. In some embodiments, the distalportion 100 includes bulbs having a first shape in a distal section andbulbs having a second different shape in a proximal section.

In some embodiments in which a bulb comprises an egg, oval or ellipticalshape, a tapered portion of the bulb facing the distal end of the distalportion 100 can aid navigation to increasingly small vessels, forexample at the transition point to a smaller vessel. For example, thetapered end of can help the distal portion 100 from internal carotidartery (ICA) to M1 or from M1 to M2 segments of the brain.

In some embodiments, at least some of the bulbs have a size (withrespect to the outer diameter in an expanded configuration) of about 1mm to about 80 mm (e.g., about 2 mm to about 12 mm). Bulbs in range ofabout 1 mm to about 6 mm, about 3 mm to about 4.5 mm, about 0.5 mm toabout 3 mm (e.g., about 3 mm), 0.75 mm to about 3 mm (e.g., about 3 mm),about 3.1 mm to about 3.9 mm (e.g., about 3.5 mm), about 4 mm to about4.4 mm (e.g., 4 mm), and about 4.5 mm to about 7.5 mm (e.g., about 4.5mm) may be particular beneficial for smaller clots and/or vessels (e.g.,in the brain). Bulbs in range of about 4 mm to about 10 mm and about 5mm to about 40 mm may be particular beneficial for larger clots and/orvessels (e.g., in the leg). In some embodiments, all of the bulbs have asize (with respect to the outer diameter in an expanded configuration)greater than about 0.75 mm, greater than about 1 mm, greater than about1.5 mm, greater than about 2 mm, greater than about 2.5 mm, or greaterthan about 2.75 mm. Large sizes may be particularly beneficial in someembodiments because they effectively engage or appose vessel walls, aresimpler to manufacture, etc.

The bulb sizes described herein may be reduced by about 1.3 times toabout 10 times (e.g., about 1.3 to about 2.5 times, about 2.5 to about 4times, about 4 to about 7 times, about 7 to about 10 times, andoverlapping ranges therein) in the collapsed configuration. In someembodiments, the collapsed configuration of the bulbs is about 50% toabout 80% of the inner diameter of the delivery catheter (e.g.,microcatheter). For example, in embodiments in which a microcatheter hasan inner diameter of about 0.0125 inches (approx. 0.32 mm), the bulbs inthe collapsed state can have a diameter between about 0.006 inches(approx. 0.16 mm) and about 0.01 inches (approx. 0.25 mm). In someembodiments, for example for use in small vessels, the bulbs may have asize in the collapsed state of about 0.1 mm and about 0.9 mm (e.g.,about 0.25 mm to about 0.5 mm). In some embodiments, for example for usein small vessels, the bulbs may have a size in the collapsed state ofabout 0.5 mm and about 5 mm.

In some embodiments, the dimensions of the bulbs vary based on the shapeof the bulb. For example, the diameter may vary if the shape is asphere. For another example, the diameter and/or length may vary if theshape is oblong. For yet another example, the length of a side and/orthe angle of a vertex of a may vary if the shape of is a polygon (e.g.,triangle).

The diameter or width of the distal portion 100 varies along the lengthof the distal portion 100. Examples of diameters or widths of bulbs aredescribed above. In some embodiments, the diameter or width of the necksbetween, proximal to, and/or distal to bulbs is in the range of about0.15 mm to about 0.75 mm, about 0.35 mm to about 0.65 mm (e.g., about0.38 mm), or about 0.4 mm to about 0.45 mm in an expanded configurationand in the range of about 0.1 mm to about 0.5 mm, about 0.1 mm to about0.34 mm, about 0.27 mm to about 0.37 mm, or about 0.25 mm to about 0.33mm (e.g., about 0.32 mm) in the collapsed configuration. In someembodiments, the diameter or width of the distal portion 100 is in therange of about 0.1 mm to about 0.34 mm (e.g., about 0.25 mm to about0.33 mm) in the collapsed configuration, for example small enough to fitin the smallest currently commercially available microcatheter, whichhas an inner diameter of 0.017 inches (approx. 0.43 mm). In someimplementations, for example in which the device is configured to beused in larger vessels, the diameter or width of the distal portion 100is in the range of about 1 mm to about 40 mm (e.g., about 5 mm to about20 mm) in the expanded configuration and the in the range of about 0.5mm to about 10 mm (e.g., about 1 mm to about 2 mm) in the collapsedconfiguration.

The diameter or dimension of the necks may be the same or different. Forexample, the diameters of the necks may vary across the longitudinallength of the distal portion 100. In some embodiments, the diameter ofthe neck at least partially depends on the size of one or both adjacentbulbs. For example, referring again to FIG. 2B, the diameter of thenecks 1120 between the bulbs 1118 may be larger than the diameter of thenecks 1120 between the bulbs 1116, which may be larger than the diameterof the necks 1120 between the bulbs 1114, which may be larger than thediameter of the necks 1120 between the bulbs 1112. In some embodiments,varying the diameter or dimension of the necks with variance in thediameter or dimension of the bulbs can help to vary or maintain anundulation pattern, which can help to trap thrombus and/or inhibit orprevent distal emboli with enhanced wall apposition by the bulbs 1110and the necks 1120.

In some embodiments, starting at the distal end of the distal portion100, each consecutively proximal bulb is larger than the other. In someembodiments, two or more bulb sizes may be in an alternating pattern. Asan example, a series of three bulb sizes may be alternated seven timesfor a total of twenty-one bulbs. In some embodiments, three or more bulbsizes are in a series, and each series is repeated two, three, four,five, six, seven, or more times. In some embodiments, larger bulbs maybe at the ends of the distal portion 100, while smaller bulbs are in themiddle of the distal portion 100. In some embodiments, smaller bulbs maybe at the ends of the distal portion 100, while larger bulbs are in themiddle of the distal portion 100. In some embodiments, the distalportion 100 comprises bulbs of varying dimensions without specificity toa longitudinal position.

The positioning or spacing of the bulbs may be beneficial for certainvessel sizes and/or clot locations, material, and/or sizes. Bulbs may betouching (e.g., contiguous) or non-touching. The distal portion 100 mayinclude bulbs that are both touching and non-touching. In someembodiments, the distal portion 100 includes bulbs that are allnon-touching and/or are spaced apart by one or more necks. These necksmay be of the same or different material than the bulbs. The necks mayalso be shaped differently than the bulbs. The necks may comprise, beembedded with, or coated by markers or other visualization aids (such asradiopaque portions).

The bulbs may be separated by distances of about 0.1 mm to about 50 mm,including, but not limited to, about 0.5 mm to about 1 mm, about 1 mm toabout 2 mm, about 2 mm to about 3 mm, about 3 mm to about 4 mm, about 4mm to about 5 mm, about 5 mm to about 8 mm, about 8 mm to about 10 mm,about 10 mm to about 12 mm, about 12 mm to about 15 mm, about 15 mm toabout 25 mm, about 25 mm to about 35 mm, and about 35 mm to about 50 mmapart, including overlapping ranges thereof. The spaces between thebulbs in the distal portion 100 may be constant, or spacing between twoor more (or all) of the bulbs may be different. In some embodiments,some bulbs are spaced the same distance from one another, while otherbulbs have different spacing. In some embodiments, the length of thenecks can at least partially depend on the length of at least oneadjacent bulb. For example, the length of a neck may be between about0.25 to about 2 times the length of a bulb proximal thereto, a bulbdistal thereto, or an average length of the bulbs proximal and distalthereto. The necks can be more than an inert link between two bulbs. Forexample, when a distal portion 100 is torsionally rasped, longer necksmay be squeezed tighter as they are rotated, allowing the bulbs aheadand behind to bulge even further. When the necks are the same length anda distal portion 100 is torsionally rasped, each of the necks will besqueezed moderately, resulting in moderate radial force out of thepreceding and following bulbs.

In some embodiments, lengths of the necks may be at least partiallybased on the size and quantity of the bulbs the desired length of thedistal portion 100, and/or the desired length of a distal neck 65,described further herein. For example, if the desired length of thedistal portion 100 is about 60.5 cm, if three spherical bulbs having adiameter of about 3 mm, three spherical bulbs having a diameter of about3.5 mm, two spherical bulbs having a diameter of about 4 mm, and twospherical bulbs having a diameter of about 4.5 mm are desired, andapproximately equal spacing with a distal neck 65 having a length ofabout 4 mm, the necks may have a length of about 2 mm including a neckproximal to the proximal-most bulb.

Neck shapes may include, for example, e.g., with respect to across-section, at least one of a circle, oblong, egg, oval, ellipse,triangle, rectangle, parallelogram, rhombus, square, diamond, pentagon,hexagon, heptagon, octagon, nonagon, decagon, quatrefoil, trapezoid,trapezium, other polygons, curvilinear or bulged versions of these andother shapes, combinations thereof (e.g., a distal section of neckhaving a different shape than a proximal section of a neck), and thelike. Different shapes of necks may be used in a distal portion 100. Insome embodiments, the distal shape of the neck at least partiallydepends on the shape of at least one adjacent bulb.

The distal portion 100 may be braided, knitted, or woven with two ormore strands (e.g., about 6 strands to about 144 strands, about 12strands to about 120 strands, about 12 strands to about 96 strands,about 12 strands to about 72 strands, about 48 strands) in someembodiments. Strands may include filaments, wires, ribbons, etc. havinga circular cross-section, an arcuate non-circular cross-section (e.g.,oval, ellipsoid, etc.), a rectangular cross-section (e.g., square), atrapezoidal cross-section, combinations thereof, and the like. In someembodiments, the number of strands of a distal portion 100 is at leastpartially based on the desired expanded configuration diameter of thedistal portion 100. For example, in some embodiments, 32 strands areused for a distal portion 100 expanded configuration diameter rangingfrom 2.5 mm and smaller, 48 strands are used for a distal portion 100expanded configuration diameter ranging from about 2.5 mm to about 4.5mm, 64 strands are used for a distal portion 100 expanded configurationdiameter ranging from about 4.5 mm to about 6.0 mm, 72 strands are usedfor a distal portion 100 expanded configuration diameter ranging from6.0 mm and greater, etc. In some embodiments, the strands have adiameter between about 0.0005 inches (approx. 0.013 mm) and about 0.04inches (approx. 1 mm) (e.g., between about 0.0005 inches (approx. 0.013mm) and about 0.0015 inches (approx. 0.038 mm), between about 0.0008inches (approx. 0.02 mm) and about 0.012 inches (approx. 0.3 mm),between about 0.0008 inches (approx. 0.02 mm) and about 0.002 inches(approx. 0.05 mm), e.g., about 0.001 inches (approx. 0.025 mm), about0.00125 inches (approx. 0.032 mm)). As the diameter of the vessel(s) tobe treated increases, the diameter of the distal portion 100 increases,and at least one of the number of filaments, filament density, filamentdiameter, etc. may also increase, for example to provide the samedensity, picks (or pixels) per inch (PPI), etc. of the distal portion100 or a portion thereof. In some embodiments, the necks have a uniformPPI.

The thickness or diameter of filaments comprising shape memory materialmay influence mechanical properties such as hoop strength, for examplethicker filaments imparting more hoop strength. The thickness ordiameter of filaments comprising radiopaque material may influence thevisibility under x-ray and/or fluoroscopy, for example thicker filamentsbeing easier to visualize. In some embodiments, the distal portion 100comprises a shape memory filament having a first diameter or thicknessand a radiopaque filament having a second diameter or thicknessdifferent than the first diameter or thickness. Different thicknesses ordiameters can, for example allow adjustment to filament size based atleast partially on the intended use of that filament. For example, iflarge hoop strength is not desired but high visibility is desired,relatively lower diameter shape memory filaments and relatively largerradiopaque filaments may be used. Other combinations are also possible.For example, in some embodiments, the distal portion 100 comprises afirst shape memory filament having a first diameter or thickness and asecond shape memory filament having a second diameter or thicknessdifferent than the first diameter or thickness. For another example, insome embodiments, the distal portion 100 comprises a first radiopaquefilament having a first diameter or thickness and a second radiopaquefilament having a second diameter or thickness different than the firstdiameter or thickness.

In some embodiments, the distal portion 100 is configured to allow theuser of a device 10, 20, 30, 40 to crowd, compress, or bunch parts ofthe distal portion 100 such that some parts of the distal portion 100have a higher density in some sections than in other sections, which maybe useful, for example, for removing stubborn clots inhibiting orpreventing inadvertent emboli, and/or decreasing flow into an aneurysmor an arterio-venous fistula to aid thrombosis.

The distal portion 100 may have a length in the range of about 0.5 cm toabout 20 cm (e.g., about 1 cm to about 20 cm, about 5 cm to about 10 cm,about 4 cm to about 8 cm, etc.). In some implementations, for example inwhich the device is configured to be used in larger vessels (e.g.,outside the brain), the distal portion 100 may have a length greaterthan about 20 cm (e.g., about 20 cm to about 50 cm). The length of thedistal portion 100 may be characterized by the length of the distalportion 100 configured to appose the sidewalls of a vessel. For example,the length of the distal portion 100 may be characterized byapproximately the center of the proximal-most bulb to the center of thedistal-most bulb. In some embodiments, the usable length of the distalportion is between about 5 mm and about 60 mm (e.g., about 55.25 mm,which would be slightly oversized for treatment of any clot up to about55 mm in length). As described further herein, the entire length of thedistal portion 100 need not be used in every procedure.

The distal portion 100 may have a wall thickness, in some embodiments,ranging from about 0.01 mm to about 4 mm, about 0.02 mm to about 1 mm,or about 0.02 mm to about 0.05 mm (e.g., about 0.025 mm). The wallthickness may be between the thickness or diameter of one strand and thethickness or diameter of two strands (e.g., at a strand crossing point),in accordance with strand dimensions described herein. In someembodiments, the distal neck 65 or the distal end of the distal portion100 may have the same or a different wall thickness than sections of thedistal portion 100 proximal thereto. For example, the distal neck 65 orthe distal end of the distal portion 100 may have a wall thicknessbetween about 0.01 mm and about 4 mm, between about 0.02 mm and about 1mm, or between about 0.02 mm and about 0.05 mm (e.g., about 0.025 mm).In some embodiments, the distal neck 65 or the distal end of the distalportion 100 may have the same or a different number of filaments thansections of the distal portion 100 proximal thereto. For example, thedistal neck 65 or the distal end of the distal portion 100 may have anumber of filaments between about 6 and about 144, between about 12 andabout 120, between about 12 and about 96, or between about 12 and about72 (e.g., about 48). In some embodiments, the distal neck 65 or thedistal end of the distal portion 100 may have the same or a differentratio between diameter or dimension in an expanded state to diameter ordimension in a collapsed state. For example, the distal neck 65 or thedistal end of the distal portion 100 may have a ratio between about 1:1(e.g., collapsed state and expanded state are the same) and about 10:1(e.g., about 1.2:1).

At least some of the strands of the distal portion 100 may comprise ashape memory alloy (e.g., nickel titanium or cobalt chromium). In someembodiments, about 50% to about 95% (e.g., about 75%) of the strands ofthe distal portion 100 comprise a shape memory alloy (e.g., nickeltitanium, cobalt chromium, etc.) and about 5 to about 50% (e.g., 25%) ofthe strands of the distal portion 100 comprise a radiopaque material(e.g., platinum iridium, platinum tungsten, etc.). In some embodiments,the distal portion 100 comprises between about 1 strand and about 144strands, between about 1 strand and about 120 strands, between about 1strand and about 60 strands, between about 2 strands and about 48strands (e.g., about 36 strands), etc. comprising a shape memory alloy(e.g., nickel titanium, cobalt chromium, etc.). In some embodiments, thedistal portion 100 comprises between about 1 strand and about 60strands, between about 1 strand and about 48 strands, between about 2strands and about 24 strands (e.g., about 12 strands), etc. comprising aradiopaque material (e.g., platinum iridium, platinum tungsten, etc.).The shape memory filaments may help with heat treating to an expandeddistal portion 100 shape, and the radiopaque filaments may aid invisualizing the device under x-ray and/or fluoroscopy during a procedureusing the distal portion 100. The radiopaque strands can be spaced orclustered to increase visibility under x-ray and/or fluoroscopy. Forexample, a thick-band pattern may be used, which can include a pluralityof radiopaque strands (e.g., 2 to 12 radiopaque strands) that arecircumferentially adjacent.

In some embodiments, the distal portion 100 (e.g., the elongate supportstructure and/or the bulbs) comprises filaments including materials thatare biocompatible or surface-treated to produce biocompatibility.Suitable materials may include, for example, platinum, titanium, nickel,chromium, cobalt, tantalum, tungsten, iron, manganese, molybdenum, andalloys thereof including nickel titanium (e.g., nitinol), nickeltitanium niobium, chromium cobalt, copper aluminum nickel, ironmanganese silicon, silver cadmium, gold cadmium, copper tin, copperzinc, copper zinc silicon, copper zinc aluminum, copper zinc tin, ironplatinum, manganese copper, platinum alloys, cobalt nickel aluminum,cobalt nickel gallium, nickel iron gallium, titanium palladium, nickelmanganese gallium, stainless steel, shape memory alloys, etc. Suitablematerials may also include polymers such as polylactic acid (PLA),polyglycolic acid (PGA), poly lactic co-glycolic acid (PLGA),polycaprolactone (PCL), polyorthoesters, polyanhydrides, and copolymersthereof. Suitable materials may also include alloys (e.g., nitinol,chromium cobalt, platinum tungsten, etc.) and combinations of materials(e.g., filaments with a radiopaque core or cladding in combination witha cladding or core, respectively, of a different material, a pluralityof filaments including different materials, etc.). In some embodiments,the distal portion 100 comprises nitinol and platinum tungsten.

In some embodiments, prior to braiding, the shape memory filaments arecold worked (e.g., without heat treatment). In some embodiments, priorto braiding, the shape memory filaments are straight annealed (e.g.,undergone heat treatment and straightened as a wire).

In some embodiments, the braid pattern of the distal portion 100 isone-over-one-under-one, one-over-one-under-two, one-over-two-under-two,two-over-one-under-one, two-over-one-under-two,three-over-one-under-one, three-over-one-under-two,three-over-one-under-three, three-over-two-under-one,three-over-two-under-two, three-over-three-under-one,three-over-three-under-two, three-over-three-under-three,two-over-two-under-one, two-over-two-under-two, etc. In someembodiments, a braid pattern of one-over-one-under-one can results inthe highest radial force and smallest pore size. Other patterns mayresult in a relatively higher pore size and/or relatively lower radialforce. The braid pattern may be constant along the entire length of thedistal portion 100, or may vary, for example along the longitudinal axisof the distal portion 100. For example, the braid pattern may varybetween the necks and bulbs, from proximal to distal, etc. The braidpattern or filament crossover pattern, which is generally due torotation and spinning of the braiding device or carrier braider duringbraiding, is different than a radiopaque banding pattern, which isgenerally due to the arrangement of the filaments on the spools orcarriers prior to braiding and/or the rotation and spinning of thebraiding device or carrier braider.

The braid angle is the angle between the filaments and an axisperpendicular to the longitudinal or production axis of the distalportion 100, which can range from about 0° to about 180°. FIG. 4L is aschematic side elevational view of still another example embodiment of adistal portion 4800 of a vascular treatment device, for example thedistal portion 100 of the device 10, 20, 30 or 40. The distal portion4800 comprises a plurality of filaments including left-leaning filaments4815 and right-leaning filaments 4825 that are woven over a longitudinalor production axis 4840. FIG. 4M is a schematic side elevational view ofstill another example embodiment of a distal portion 4900 of a vasculartreatment device, for example the distal portion 100 of the device 10,20, 30 or 40. The distal portion 4900 comprises a plurality of filamentsincluding left-leaning filaments 4915 and right-leaning filaments 4925that are woven over a longitudinal or production axis 4840. In each ofFIGS. 4L and 4M, an axis that is perpendicular to the longitudinal orproduction axis 4840 is the braid axis 4850. The relative speed ofrotation of the horn gear in the horizontal plane, which is part of thebraider device or carrier braider as described herein, and the motion ofthe puller in the vertical direction 164 can at least partiallydetermine the braid angle. The left-leaning filaments 4815, 4915 have abraid angle (BA_(L)) 4810, 4910 and the right-leaning filaments 4825,4925 have a braid angle (BA_(R)) 4820, 4920. The braid angle 4810, 4910of the left-leaning filaments 4815, 4925 is the obtuse angle 4810, 4910formed by each left-leaning filament 4815, 4915 and the braid axis 4850.The braid angle 4820, 4920 of the right-leaning filaments 4825, 4925 isthe obtuse angle 4820, 4920 formed by each right-leaning filament 4825,4925 and the braid axis 4850. In the embodiment illustrated in FIG. 4L,the braid angle 4810 is about 120° and the braid angle 4820 is about120°. In the embodiment illustrated in FIG. 4M, the braid angle 4910 isabout 155° and the braid angle 4920 is about 155°.

In some embodiments in which the filaments 4815, 4825, 4915, 4925 extendfrom spools mounted on the spindles of a braider device or carrierbraider that are symmetrically arranged, the BA_(L)=BA_(R), which canresult in symmetric pore sizes for the distal portion 100. In someembodiments in which the filaments 4815, 4825, 4915, 4925 extend fromspools mounted on the spindles of a braider device or carrier braiderthat are asymmetrically arranged, the BA_(L) and BA_(R) can bedifferent, which can result in asymmetric pore sizes for the distalportion 100.

The interlacing angle is the angle between the right-leaning filaments4825, 4925 and the left-leaning filaments 4815, 4915 of the distalportion 100, which can range from about 0° to about 180° (e.g., about 0°to about 90°). In the embodiment illustrated in FIG. 4L, the interlacingangle 4830 is about 60°. In the embodiment illustrated in FIG. 4M, theinterlacing angle 4930 is about 130°.

In some embodiments, braid angle may be influenced by a ratio betweenthe speed of rotation S_(h) of the circular horn gear or yarn wheel andthe speed of motion S_(v) in the vertical direction of the puller(S_(h)/S_(v)). For example, if the speed of rotation S_(h) is slowerthan the speed of motion S_(v) (e.g., when the horn gear ratioS_(h)/S_(v) is less than 1.0), a relatively low braid angle can beobtained, for example as illustrated in FIG. 4M. For another example, ifthe speed of rotation S_(h) is faster than the speed of motion S_(v)(e.g., when the horn gear ratio S_(h)/S_(v) is greater than 1.0), arelatively high braid angle can be obtained, for example as illustratedin FIG. 4L. The braid angle may influence, for example, the overallradial force of the distal portion 100 as exerted on the walls of thevessel. In some embodiments, the braid angle is in the range of about45° to about 179°, about 130° to about 160° (e.g., about 151°), about95° to about 125° (e.g., about 111°, about 112°), etc. Braid anglesbelow about 50° may lack radial strength and/or be too porous. In someembodiments, the average radial resistive force (RRF), which is ameasure of the radial outward force that the distal portion 100 exertsas it resists compression, the hoop strength, which is a measure of theability of a distal portion 100 to withstand radial compressive forces,and/or the chronic outward force (COF), which is a measure of the forcethat the distal portion 100 exerts as it expands to its expanded state,along the distal portion 100 is between about 2 mm Hg (approx. 0.27kilopascals (kPa)) and about 50 mm Hg (approx. 6.7 kPa). In someembodiments, the differential force (e.g., COF minus RRF) is sufficientto expand a target vessel between about 0% and about 30% (e.g., betweenabout 0% and about 10%, between about 10% and about 20%, between about20% and about 30%, and overlapping ranges thereof). In some embodiments,the force of the device (e.g., one or more bulbs) is sufficient toentangle the clot without perforating the vessel.

PPI is an example parameter reflecting how much filament material existsin a square inch (approx. 6.5 cm²) of the distal portion 100. FIG. 4N isa schematic side elevational view of an example square inch (approx. 6.5cm²) of an example embodiment of a distal portion 2700 of a vasculartreatment device, for example the distal portion 100 of the device 10,20, 30, or 40. FIG. 4N illustrates a one-over-one-under-one braidpattern with pores 2710 being created by the intersection of a pluralityof crossing filaments 156, which may comprise shape memory materialand/or radiopaque material. The PPI may range from about 30 PPI to about300 PPI, about 30 PPI to about 75 PPI (e.g., about 32 PPI, about 57PPI), about 150 PPI to about 190 PPI (e.g., about 171 PPI), about 75 PPIto about 125 PPI (e.g., about 104 PPI), about 143 PPI to about 171 PPI(e.g., about 157 PPI), about 125 PPI to about 175 PPI (e.g., about 143PPI), etc. Higher PPI can result in smaller pore size, which can inhibitor prevent debris and small thrombi from being uncaptured, dislodgedduring capture, and/or released into downstream vasculature (e.g., inthe brain). Higher PPI can result in a smaller pore size, which candecrease flow into an aneurysm or a vascular malformation such as anarterio-venous fistula, which can aid in thrombosis of the aneurysm orvascular malformation. Lower PPI can result in a larger pore size, whichcan allow adequate flow into perforating vessels or small blood vessels,which can maintain flow in these small but important blood vessels.Porosity between about 60% and about 78% may decrease flow intoaneurysms or vascular malformations including arterio-venous fistulaeand/or permit perfusion to branch vessels.

Pore size is another example parameter reflecting the amount of filamentmaterial, and is the size of a hole or aperture or pore created by theintersection of a plurality crossing filaments. Pore dimensions are acorollary to PPI, but they are different in that PPI is a measure of theamount of metal or filaments you would find in a square inch. Inembodiments in which the braid pattern is one-over-one-under-one, forexample, referring again to FIG. 4N, four crossing filaments may createa quadrilateral-shaped (e.g., rectangle, square, parallelogram, rhombus,diamond, trapezoid) pore. Pores may be large enough to permit perfusionof blood (e.g., at least about 5 microns or micrometers (μm)) to atleast about 7 μm should permit red blood cells to pass therethrough),but small enough to trap stroke-causing debris, which generally has asize greater than about 200 μm. In some embodiments, the distal portion100 comprises pores having a diameter or dimension (e.g., length of aside) between about 0.02 mm² and about 1 mm², between about 0.02 mm² andabout 0.05 mm², or between about 0.02 mm² and about 0.025 mm².

In some embodiments, the pore size is substantially uniform across theentire distal portion 100. In some embodiments, the pore size variesacross the length of the distal portion 100. For example, the pore sizemay be substantially uniform along necks and vary along bulbs. Foranother example, variable pore size may take into account bulbsextending radially outward from necks, and reducing the pore size in thelargest dimension areas of the bulbs can help to inhibit debris frombeing released (e.g., into the brain).

A ratio of the diameter of a filament in the distal portion 100 (e.g.,in mm) to the area of the pore between the filaments in the distalportion (e.g., in mm²) may be about 1:1 (e.g., in 1/mm), for example onaverage along the length of the distal portion 100. In some embodiments,the ratio may be about 1:0.5, about 1:0.6, about 1:0.7, about 1:0.8,about 1:0.9, about 1:1, about 1:1.2, about 1:1.3, about 1:1.4, or about1:1.5. Larger and smaller ratios are also possible.

In some embodiments, increased outward expansile force and/orcompression resistance can be provided by a higher braid angle and/orhigher PPI. In some embodiments, the force/resistance (e.g., radialforce) is in a range sufficient to expand target vessel(s) in the rangeof about 0% to about 30%. In some embodiments, the total diameter of thedistal portion 100 in the expanded state is about 0.5 mm to about 1.5 mmgreater than the diameter of the target vessel(s). In some embodiments,the total diameter or size of the distal portion 100 in the expandedstate is oversized by about 10% to about 50% with respect to thediameter of the target vessel(s), which can provide radial forcesufficient to appose the sidewalls of the vessel and/or slightly expandthe vessel and to inhibit debris from flowing between the vessel wallsand bulbs of the distal portion 100.

In some embodiments, forming the distal portion 100 includes cutting(e.g., sheared, clipping, trimming, severing, or the like) the distalends of the filaments of the distal portion 100. In some embodiments,the cut distal ends of the filaments of the distal portion 100 are leftloose, with no further treatment. In certain such embodiments, the sizeof the filaments allows them to be flexible enough to not puncturetissue. In some embodiments, after cutting, the distal ends of thefilaments of the distal portion 100 may be treated in a variety of ways.For example, the distal ends of the filaments of the distal portion 100may be bent back, welded (e.g., ball welded), polished (e.g., to a dullend), coupled in sleeves, dip coated (e.g., in polymer such aspolyurethane), coupled (e.g., adhered, welded, etc.), for example to anarcuate member (e.g., a radiopaque marker band, for example asillustrated in FIG. 5D), combinations thereof, and the like.

In some embodiments, forming the distal portion 100 includes cutting(e.g., sheared, clipping, trimming, severing, laser cut, combinationsthereof, and the like) the proximal ends of the filaments of the distalportion 100. In some embodiments, the lengths of the distal neck 65,bulbs, and necks between bulbs have a predetermined length, and thelength of an optional neck proximal to the proximal-most bulb can beused to control the total length of the distal portion 100. The proximalends of the filaments of the distal portion may be coupled to theproximal portion 200, as described further herein. The length of theproximal neck may take into account the length of the joint 300.

In some embodiments, the bulbs are integral with the necks in the distalportion 100. For example, the plurality of woven filaments may make upthe bulbs and the necks between, proximal to, and/or distal to thebulbs. In some embodiments, the filaments may extend continuouslylongitudinally from a proximal end of the distal portion to a distal endof the distal portion 100. In some embodiments, the filaments may extendcontinuously longitudinally for a portion of the distal portion 100(e.g., including one bulb and one neck, including a plurality of bulbsand a plurality of necks, including a plurality of bulbs and one neck,including one bulb and a plurality of necks, etc.).

In some embodiments, the bulbs are coupled (fixably or reversiblycoupled) on or along an elongate support structure (such as a neck,tube, spindle, spine, rod, backbone, etc.). For example, the bulbs maybe welded, glued, soldered, dip-coated, spray-coated, combinationsthereof, and the like to the elongate support structure. The elongatesupport structure may be hollow, filled, or partially hollow. Theelongate support structure may comprise a wire, a woven tubular member,a hypotube, combinations thereof, and the like. In certain suchembodiments, the distal portion 100 may comprise a single elongatesupport structure or a plurality of elongate support structures (e.g., aseries of tubular members between bulbs).

FIGS. 2A, 2B, 3A, 3B, 4A, 4B, and 4I-4K illustrate an optional distalneck 65, which extends distally from the distal-most bulb. The distalneck 65 may be cylindrical or substantially cylindrical, although theproximal end of the distal neck 65 may flare outwardly to begin thedistal-most bulb. In some embodiments, in an expanded configuration, thedistal neck 65 has an outer diameter of less than about 0.017 inches(approx. 0.43 mm) and, in a collapsed configuration, has an outerdiameter of less than about 0.0125 inches (approx. 0.32 mm). In someembodiments, the distal neck 65 has a diameter in the expandedconfiguration in the range of about 0.35 mm to about 0.65 mm (e.g.,about 0.40 mm to about 0.45 mm). In some embodiments, the distal neck 65has a diameter in the collapsed configuration in the range of about 0.1mm to about 0.34 mm (e.g., about 0.25 mm to about 0.33 mm). In someembodiments, for example in which the device is configured to be used inlarger vessels (e.g., the leg, outside the brain), the distal neck inthe expanded configuration has a diameter in the range of about 1 mm toabout 40 mm and in the collapsed configuration has a diameter in therange of about 0.5 mm to about 10 mm. In some embodiments, a ratio ofthe diameter of the distal neck 65 in the expanded configuration to thediameter of the distal neck 65 in the collapsed configuration is about1.2:1 to about 10:1. Smaller ratios may be useful, for example, insmaller vessels, and larger ratios may be useful, for example, in largervessels. In some embodiments, the distal neck 65 is narrow and hassimilar outer diameter in the expanded and collapsed configuration. Thedistal neck 65 may have a length that ranges from about 1 mm to about 5mm. The length of the distal neck 65 may at least partially depend onthe desired usable length of the distal portion 100, parameters of thebulbs, and/or parameters of the neck. For example, a length of thedistal neck 65 may be a multiple of an average length of necks betweenbulbs (e.g., about 1.5 times to about 2.5 times, e.g., about 2 times).In some embodiments, the distal neck 65 may have a pigtail or othershape that can make the distal neck 65 more atraumatic.

Proximal to the proximal-most bulb, FIGS. 2A, 2B, 3A, 3B, 4A, 4B, and4I-4K illustrate a proximal portion 200 and a marker band 25, forexample as further discussed herein. Although illustrated in FIGS. 2A,2B, 3A, 3B, 4A, 4B, and 4I-4K as being coupled to the distal portion1000, 1100, 1200, 1300, 1400, 1500, 1900, 2000, 2100 proximal to theproximal-most bulb as schematically illustrated in FIG. 1A, the proximalportion 200 may be coupled to the distal portion 1000, 1100, 1200, 1300,1400, 1500, 1900, 2000, 2100 distal to the distal-most bulb, for exampleas schematically illustrated in FIG. 1B, the proximal portion 200 may becoupled to the distal portion 1000, 1100, 1200, 1300, 1400, 1500, 1900,2000, 2100 distal to the distal-most bulb and proximal to the distal endof the proximal portion 200, for example as schematically illustrated inFIG. 1C, or the proximal portion 200 may be coupled to the distalportion 1000, 1100, 1200, 1300, 1400, 1500, 1900, 2000, 2100 proximal tothe distal-most bulb, for example as schematically illustrated in FIG.1D.

FIGS. 2A, 2B, 3A, 3B, 4A, 4B, 4I, 4J, and 4K illustrate exampleembodiments of distal portions 1000, 1100, 1200, 1300, 1400, 1500, 1900,2000, 2100 in which each of the longitudinal axes of the necks 1020,1120, 1220, 1320, 1420, 1520, 1920, 2020, 2150 is substantially alignedwith or substantially the same as the longitudinal axis of the distalportion 1000, 1100, 1200, 1300, 1400, 1500, 1900, 2000, 2100, which insome embodiments can allow the distal portions 1000, 1100, 1200, 1300,1400, 1500, 1900, 2000, 2100 to exert substantially even radial forceson the sidewalls of a vessel being treated. In some embodiments,referring again to FIGS. 4C and 4E, the longitudinal axes 2230, 2430 ofthe necks 2220, 2420 may be non-aligned with longitudinal axes of thedistal portion 2200, 2400. For example, in embodiments in which thedistal portion 2200, 2400, comprises spherical bulbs, the longitudinalaxes 2230, 2430 of the necks 2220, 2420 may be aligned along chords ofthe spheres, which in some embodiments can allow the distal portions2200, 2400 to exert substantially uneven radial forces on the sidewallsof a vessel being treated, which may be useful, for example, to dislodgeclots adherent to the endothelium. Each of the following embodiments ispossible: coaxially aligned necks with substantially uniform diameterand substantially uniform lengths; coaxially aligned necks withsubstantially uniform diameter and varying lengths; coaxially alignednecks with varying diameters and substantially uniform lengths; andcoaxially aligned necks with varying diameters and varying lengths.

In some embodiments, referring again to FIG. 4E, in which the distalportion 2400 comprises spherical bulbs 2410, 2415, the longitudinal axesof the necks may be aligned along different chords of the spheres, forexample connecting different parts of the circumferences of the bulbs.For example, the necks may alternate about 180° between an upperlongitude and a lower longitude. For another example, the necks maycircumferentially rotate about 90°, about 120°, etc. between each bulb.In some embodiments in which the distal portion 2500 comprisestriangular bulbs, the longitudinal axes of the necks may be alignedalong different axes of the triangles, referring again to FIG. 4G, forexample shifting vertices between each bulb 2510. Phase shifting of theneck positions, or viewed alternatively as phase-shifting of the bulbshapes, along the longitudinal axis of the distal portion 2500 can helpto capture stubborn or aged clots.

FIG. 5A is a schematic side elevational view of another exampleembodiment of a distal portion 1600 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 1600 includes, in an expanded state, a cylindricalwide-mouthed textile structure that expands radially outwardly fromproximal to distal, and then stays at the larger diameter until thedistal end. FIG. 5B is a schematic side elevational view of yet anotherexample of a distal portion 2300 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 2300 includes, in an expanded state, a proximal neck 70and a wave-shaped wide-mouthed textile structure that alternatinglyexpands radially outwardly to a peak or hill 2310 and radially inward toa valley 2320 from proximal to distal and then stays at the largerdiameter until the distal end 75. The expanding section may be generallyhemispherical (e.g., as illustrated in FIG. 5A), wave-shaped (e.g., asillustrated in FIG. 5B), tapered, stepped, combinations thereof, and thelike. The distal-most bulb of distal portions described herein may beadapted to extend radially outward from the longitudinal axis,increasing in diameter from proximal to distal, reaching an intermediatepoint, and then staying at the intermediate diameter (e.g., without adistal neck 65). The distal portions 1600, 2300 may be useful, forexample, for apposing sidewalls of a vessel along substantially anentire length of a clot and/or for apposing sidewalls of a vessel havingan aneurysm or a vascular malformation such as an arterio-venousfistula, which can decrease flow into the aneurysm or the vascularmalformation such as an arterio-venous fistula and aiding thrombosis.

FIG. 5C is a schematic side elevational view of still another exampleembodiment of a distal portion 1700 of a vascular treatment device, forexample the distal portion 100 of the device 10 20, 30, or 40. Thedistal portion 1700 includes, in an expanded state, one elongate bulb1705, a proximal neck 70, and a distal neck 65. FIG. 5D is a schematicside elevational view of still yet another example embodiment of adistal portion 1710 of a vascular treatment device, for example thedistal portion 100 of the device 10, 20, 30, or 40. The distal portion1710 illustrated in FIG. 5D, like the distal portion 1700 illustrated inFIG. 5C, includes one elongate bulb 1705, a proximal neck 70, and adistal neck 65. The distal portion 1710 also includes a radiopaquemarker band 1720 coupled to the distal end of the distal neck 65, whichmay be used to determine the position of the bulb 1705 within a vessel.FIG. 5D also illustrates a radiopaque marker band 25 coupled to thedistal end of the proximal portion 200, discussed in further detailherein. The distal portions 1700, 1710 may be useful, for example, forapposing sidewalls of a vessel along substantially an entire length of aclot, and radially inwardly displacing filament ends (e.g., to furtherreduce the risk of puncturing tissue).

The mouths, or open end, at the proximal end of the distal portion 100and at the distal end of the distal portion 100 may be wide (e.g., asillustrated by the distal end of the distal portion 1600 in FIG. 5A, thedistal portion 2300 in FIG. 5B) or narrow (e.g., as illustrated by thedistal end of the distal portion 1700 in FIG. 5C and the distal end ofthe distal portion 1710 in FIG. 5D). Each of the following embodimentsis possible: a distal portion 100 including a wide mouth at the distalend and a wide mouth at the proximal end; a distal portion 100 includinga wide mouth at the distal end and a narrow mouth at the proximal end; adistal portion 100 including a narrow mouth at the distal end and a widemouth at the proximal end; and a distal portion 100 including a narrowmouth at the distal end and a narrow mouth at the proximal end. A narrowmouth at the distal end of the distal portion 100 can help navigation toincreasingly smaller vessels and/or may serve as an atraumatic distaltip. A narrow mouth at the proximal end of the distal portion 100 canhelp insertion into the distal end of a proximal portion 200 (e.g., asdescribed with respect to FIGS. 20A-23C). A wide mouth at the distal endand the proximal end of the distal portion 100 can help with wallapposition (e.g., the distal end at least partially acting as an embolicfilter and/or when the distal portion 100 is used to treat aneurysms orvascular malformations such as arterio-venous fistula).

FIG. 5E is a schematic side elevational view of another exampleembodiment of a distal portion 1800 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 1800 includes, in an expanded state, one generallyspherical distal bulb 1802, one generally proximal elongate bulb 1804, aneck 1806 between the bulb 1802 and the bulb 1804, a proximal neck 1809,and a distal neck 65. The neck 1806 has a shorter length than theproximal neck 1809 and the distal neck 1808. FIG. 5E also illustrates aradiopaque marker band 25 coupled to the distal end of the proximalportion 200, discussed in further detail herein. The distal portion 1800may be useful, for example, for apposing sidewalls of a vessel alongsubstantially an entire length of a clot, providing a distal bulb 1802that can act as a distal embolic protection device, and radiallyinwardly displacing filament ends (e.g., to further reduce the risk ofpuncturing tissue).

FIG. 5F is a schematic side elevational view of yet another exampleembodiment of a distal portion 1810 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 1810 includes, in an expanded state, one generallyspherical distal bulb 1812, one generally spherical proximal bulb 1816,one generally elongate bulb 1814 between the bulb 1812 and the bulb1816, necks 1818 between the bulbs 1812, 1814 and between the bulbs1814, 1816, a proximal neck 1819, and a distal neck 65. FIG. 5F alsoillustrates a radiopaque marker band 25 coupled to the distal end of theproximal portion 200, discussed in further detail herein. The distalportion 1810 may be useful, for example, for apposing sidewalls of avessel along substantially an entire length of a clot, providing adistal bulb 1812 that can act as a distal embolic protection device,providing a proximal spherical bulb 1816 that can be optionally deployedif a clot is longer than expected, and radially inwardly displacingfilament ends (e.g., to further reduce the risk of puncturing tissue).

FIGS. 4A, 4B, 5E, and 5F show example embodiments of a pattern of bulbshapes in which at least one of the bulbs 1412 in FIG. 4A, at least oneof the bulbs 1511 in FIG. 4B, at least one of the bulbs 1802 in FIG. 5E,and at least one of the bulbs 1812 in FIG. 5F has a shape different thanat least one of the other bulbs 1414 in FIG. 4A, at least one of theother bulbs 1531 in FIG. 4B, at least one of the other bulbs 1804 inFIG. 5E, and at least one of the other bulbs 1814 in FIG. 5F,respectively. With reference to FIG. 4B, this different or combinationshape pattern persists even when the bulbs have different sizes. In theembodiments illustrated in FIGS. 4A, 4B, 5E, and 5F, some of the bulbs1412, 1511, 1802, 1812 are spherical and some of the bulbs 1414, 1531,1804, 1814 are oblong, but distal portions 100 including bulbs havingother combinations of shapes are also possible.

FIG. 5G is a schematic side elevational view of still another exampleembodiment of a distal portion 1820 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 1820 includes, in an expanded state, one generallyelongate distal bulb 1822, one generally elongate proximal bulb 1826,one generally elongate bulb 1824 between the bulb 1822 and the bulb1826, necks 1828 between the bulbs 1822, 1824 and between the bulbs1824, 1826, a proximal neck 1829, and a distal neck 65. FIG. 5G alsoillustrates a radiopaque marker band 25 coupled to the distal end of theproximal portion 200, discussed in further detail herein. The bulb 1824is longer than the bulbs 1822, 1824. The distal portion 1820 may beuseful, for example, for apposing sidewalls of a vessel alongsubstantially an entire length of a clot, providing a distal bulb 1822that can act as a distal embolic protection device, providing a proximalbulb 1826 that can be optionally deployed if a clot is longer thanexpected, and radially inwardly displacing filament ends (e.g., tofurther reduce the risk of puncturing tissue).

FIG. 6A is a schematic side elevational view of another exampleembodiment of a distal portion 9000 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 9000 includes, in an expanded state, a plurality of wovenbulbs 9003, 9005, 9007 and necks 9020 with braid angles that vary alongthe length of the distal portion 9000. The distal portion 9000 includes,in an expanded state, one generally spherical distal bulb 9003, onegenerally spherical proximal bulb 9007, one generally elongate bulb 9005between the bulb 9003 and the bulb 9007, a neck 9014 between the bulbs9003, 9005, a neck 9016 between the bulbs 9005, 9007, a wide-mouthproximal neck 9018, and a wide-mouth distal neck 9012. In someembodiments, the distal portion 9000 includes a plurality of segments,at least one of which has a different braid angle. The distal portion9000 illustrated in FIG. 6A includes a proximal segment 9006 having arelatively low braid angle, a middle segment 9002 having a relativelyhigh braid angle, and a distal segment 9004 having a relatively lowbraid angle 9004. In some embodiments, segments 9004, 9006 may havebraid angles ranging from about 0° to about 90° (e.g., about 17°, about22°, about 45°, etc.). Lower braid angle segments generally have lowerPPI and tend to be more porous. Lower PPI can result in a larger poresize, which can allow adequate flow into perforating vessels or smallblood vessels adjoining an aneurysm or a vascular malformation such asan arterio-venous fistula, which can maintain flow in these small butimportant blood vessels. In some embodiments, the segment 9002 may havebraid angles ranging from about 91° to about 180° (e.g., about 111°,about 112°, about 151°, etc.). Higher braid angle segments generallyhave a higher PPI and tend to be less porous. Higher PPI can result in asmaller pore size, which can decrease flow into an aneurysm or avascular malformation such as an arterio-venous fistula, which can aidin thrombosis of the aneurysm or vascular malformation. The bulbs havesubstantially uniform dimensions or diameters (e.g., within about ±5%,about ±10%, about ±15%, or about 20% of each other) such that the distalportion 9000 may be considered non-tapered.

FIG. 6B is a schematic side elevational view of yet another exampleembodiment of a distal portion 9100 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 9100 includes, in an expanded state, a plurality of wovenbulbs 9103, 9105, 9107 and necks 9115 having braid angles that varyalong the length of the distal portion 9100. In some embodiments, thedistal portion 9100 includes, in an expanded state, one generallyspherical distal bulb 9103, one generally spherical proximal bulb 9107,one generally elongate bulb 9105 between the bulb 9103 and the bulb9107, a neck 9114 between the bulbs 9103, 9105, a neck 9116 between thebulbs 9105, 9107, a wide-mouth proximal neck 9118, and a wide-mouthdistal neck 9112. The distal portion 9100 illustrated in FIG. 6Bincludes a proximal segment 9120 having a relatively low braid angle anda distal segment 9110 having a relatively high braid angle. In someembodiments, the segment 9120 may have braid angles ranging from about0° to about 90° (e.g., about 17°, about 22°, about 45°, etc.). Lowerbraid angle segments generally have lower PPI and tend to be moreporous. Lower PPI can result in a larger pore size, which can allowadequate flow into perforating vessels or small blood vessels adjoiningan aneurysm or a vascular malformation such as an arterio-venousfistula, which can maintain flow in these small but important bloodvessels. In some embodiments, the segment 9110 may have braid anglesranging from about 91° to about 180° (e.g., about 111°, about 112°,about 151°, etc.). Higher braid angle segments generally have a higherPPI and tend to be less porous. Higher PPI can result in a smaller poresize, which can decrease flow into an aneurysm or a vascularmalformation such as an arterio-venous fistula, which can aid inthrombosis of the aneurysm or vascular malformation. The bulbs havesubstantially uniform dimensions or diameters (e.g., within about ±5%,about ±10%, about ±15%, or about 20% of each other) such that the distalportion 9100 may be considered non-tapered.

FIG. 6C is a schematic side elevational view of still another exampleembodiment of a distal portion 9200 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 9200 includes, in an expanded state, a plurality of wovenbulbs 9203, 9205, 9207 and necks 9215 having braid angles that varyalong the length of the distal portion 9200. The distal portion 9200includes, in an expanded state, one generally spherical distal bulb9203, one generally spherical proximal bulb 9207, one generally elongatebulb 9205 between the bulb 9203 and the bulb 9207, a neck 9214 betweenthe bulbs 9203, 9205, a neck 9216 between the bulbs 9205, 9207, awide-mouth proximal neck 9218, and a wide-mouth distal neck 9212. Insome embodiments, the distal portion 9200 includes a plurality ofsegments, at least one of which has a different braid angle. The distalportion 9200 illustrated in FIG. 6C includes a distal segment 9210having a relatively low braid angle and a proximal segment 9220 having arelatively high braid angle. In some embodiments, the segment 9210 mayhave braid angles ranging from about 0° to about 90° (e.g., about 17°,about 22°, about 45°, etc.). Lower braid angle segments generally havelower PPI and tend to be more porous. Lower PPI can result in a largerpore size, which can allow adequate flow into perforating vessels orsmall blood vessels adjoining an aneurysm or a vascular malformationsuch as an arterio-venous fistula, which can maintain flow in thesesmall but important blood vessels. In some embodiments, the segment 9220may have braid angles ranging from about 91° to about 180° (e.g., about111°, about 112°, about 151°, etc.). Higher braid angle segmentsgenerally have a higher PPI and tend to be less porous. Higher PPI canresult in a smaller pore size, which can decrease flow into an aneurysmor a vascular malformation such as an arterio-venous fistula, which canaid in thrombosis of the aneurysm or vascular malformation. The bulbshave substantially uniform dimensions or diameters (e.g., within about±5%, about ±10%, about ±15%, or about 20% of each other) such that thedistal portion 9200 may be considered non-tapered.

FIG. 6D is a schematic side elevational view of still yet anotherexample embodiment of a distal portion 9300 of a vascular treatmentdevice, for example the distal portion 100 of the device 10, 20, 30, or40. The distal portion 9300 includes, in an expanded state, a pluralityof woven bulbs 9303, 9305, 9307 and necks 9315 having braid angles thatvary along the length of the distal portion 9300. The distal portion9300 includes, in an expanded state, one generally spherical distal bulb9303, one generally spherical proximal bulb 9307, one generally elongatebulb 9305 between the bulb 9303 and the bulb 9307, a neck 9314 betweenthe bulbs 9303, 9305, a neck 9316 between the bulbs 9305, 9307, awide-mouth proximal neck 9318, and a wide-mouth distal neck 9312. Insome embodiments, the distal portion 9300 includes a plurality ofsegments, at least one of which has a different braid angle. The distalportion 9300 illustrated in FIG. 6D includes a proximal segment 9306having a relatively high braid angle, a middle segment 9320 having arelatively low braid angle, and a distal segment 9304 having arelatively high braid angle. In some embodiments, the segment 9320 mayhave braid angles ranging from about 0° to about 90° (e.g., about 17°,about 22°, about 45°, etc.). Lower braid angle segments generally havelower PPI and tend to be more porous. Lower PPI can result in a largerpore size, which can allow adequate flow into perforating vessels orsmall blood vessels adjoining an aneurysm or a vascular malformationsuch as an arterio-venous fistula, which can maintain flow in thesesmall but important blood vessels. In some embodiments, the segments9304, 9306 may have braid angles ranging from about 91° to about 180°(e.g., about 111°, about 112°, about 151°, etc.). Higher braid anglesegments generally have a higher PPI and tend to be less porous. HigherPPI can result in a smaller pore size, which can decrease flow into ananeurysm or a vascular malformation such as an arterio-venous fistula,which can aid in thrombosis of the aneurysm or vascular malformation.The bulbs have substantially uniform dimensions or diameters (e.g.,within about ±5%, about ±10%, about ±15%, or about 20% of each other)such that the distal portion 9300 may be considered non-tapered.

FIG. 6E is a schematic side elevational view of another exampleembodiment of a distal portion 9400 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 9400 includes, in an expanded state, a plurality of wovenbulbs 9403, 9405, 9407 and necks 9415 having braid angles that varyalong the length of the distal portion 9400. The distal portion 9400includes, in an expanded state, one generally spherical distal bulb9403, one generally spherical proximal bulb 9407, one generally elongatebulb 9405 between the bulb 9403 and the bulb 9407, a neck 9414 betweenthe bulbs 9403, 9405, a neck 9416 between the bulbs 9405, 9407, awide-mouth proximal neck 9418, and a wide-mouth distal neck 9412. Insome embodiments, the distal portion 9400 includes a plurality ofsegments, at least one of which has a different braid angle. The distalportion 9400 illustrated in FIG. 6E includes a proximal segment 9404having a relatively low braid angle, a segment 9408 having a mediumbraid angle, a middle segment 9430 having a relatively high braid angle,a segment 9406 having a medium braid angle, and a distal segment 9402having a relatively low braid angle. In some embodiments, the lowerbraid angle segments 9402, 9404 may have braid angles ranging from about0° to about 80° (e.g., about 17°, about 22°, about 45°, etc.). Lowerbraid angle segments generally have lower PPI and tend to be moreporous. Lower PPI can result in a larger pore size, which can allowadequate flow into perforating vessels or small blood vessels adjoiningan aneurysm or a vascular malformation such as an arterio-venousfistula, which can maintain flow in these small but important bloodvessels. In some embodiments, the higher braid angle segment 9430 mayhave braid angles ranging from about 111° to about 180° (e.g., about111°, about 112°, about 151°, etc.). Higher braid angle segmentsgenerally have a higher PPI and tend to be less porous. Higher PPI canresult in a smaller pore size, which can decrease flow into an aneurysmor a vascular malformation such as an arterio-venous fistula, which canaid in thrombosis of the aneurysm or vascular malformation. In someembodiments, the medium braid angle segments 9406, 9408 may have braidangles ranging from about 81° to about 110° (e.g., about 90°, about105°, etc.). Medium braid angle segments generally have moderate poresize and avoid for abrupt transitions in pore size, which can allow foroperator error in adequate placement of the flow diverters acrossaneurysms and blood vessels. The bulbs have substantially uniformdimensions or diameters (e.g., within about ±5%, about ±10%, about ±15%,or about 20% of each other) such that the distal portion 9400 may beconsidered non-tapered.

The variable porosities described for example with respect to FIGS.6A-6E can be combined with bulbs and necks as described herein, forexample, the plurality of woven bulbs and necks illustrated in FIGS. 6Fand 6G as described herein.

FIG. 6F is a schematic side elevational view of yet another exampleembodiment of a distal portion 9500 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 9500 includes a plurality of woven bulbs 9503, 9505, 9507and woven necks 9520. The distal portion 9500 includes, in an expandedstate, one generally spherical distal bulb 9503, one generally sphericalproximal bulb 9507, one generally elongate bulb 9505 between the bulb9503 and the bulb 9507, a neck 9514 between the bulbs 9503, 9505, a neck9516 between the bulbs 9505, 9507, a wide-mouth proximal neck 9518, anda wide-mouth distal neck 9512. In some embodiments, the distal portion9500 includes a plurality of segments, at least one of which has adifferent braid angle. The distal portion 9500 illustrated in FIG. 6Fincludes a proximal segment 9506 having a relatively low braid angle, amiddle segment 9504 having a relatively high braid angle, and a distalsegment 9502 having a relatively low braid angle. In some embodiments,the lower braid angle segments 9502, 9506 may have braid angles rangingfrom about 0° to about 90° (e.g., about 17°, about 22°, about 45°,etc.). Lower braid angle segments generally have lower PPI and tend tobe more porous. Lower PPI can result in a larger pore size, which canallow adequate flow into perforating vessels or small blood vesselsadjoining an aneurysm or a vascular malformation such as anarterio-venous fistula, which can maintain flow in these small butimportant blood vessels. In some embodiments, the higher braid anglesegment 9504 may have braid angles ranging from about 91° to about 180°(e.g., about 111°, about 112°, about 151°, etc.). Higher braid anglesegments generally have a higher PPI and tend to be less porous. HigherPPI can result in a smaller pore size, which can decrease flow into ananeurysm or a vascular malformation such as an arterio-venous fistula,which can aid in thrombosis of the aneurysm or vascular malformation.The bulbs 9510 have substantially uniform dimensions or diameters (e.g.,within about ±5%, about ±10%, about ±15%, or about 20% of each other)such that the distal portion 9500 may be considered non-tapered.

FIG. 6G is a schematic side elevational view of still another exampleembodiment of a distal portion 9600 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 9600 includes a plurality of woven bulbs 9610 and wovennecks 9620. The distal portion 9600 includes, in an expanded state, onegenerally spherical distal bulb 9603, one generally elongate proximalbulb 9607, one generally spherical bulb 9605 between the bulb 9603 andthe bulb 9607, a neck 9614 between the bulbs 9603, 9605, a neck 9616between the bulbs 9605, 9607, a proximal neck 9618, and a distal neck9612. In some embodiments, the distal portion 9600 includes a pluralityof segments, at least one of which has a different braid angle. Thedistal portion 9600 illustrated in FIG. 6G includes a proximal segment9604 having a relatively high braid angle and a distal segment 9602having a relatively low braid angle. In some embodiments, the lowerbraid angle segment 9602 may have braid angles ranging from about 0° toabout 90° (e.g., about 17°, about 22°, about 45°, etc.). Lower braidangle segments generally have lower PPI and tend to be more porous.Lower PPI can result in a larger pore size, which can allow adequateflow into perforating vessels or small blood vessels adjoining ananeurysm or a vascular malformation such as an arterio-venous fistula,which can maintain flow in these small but important blood vessels. Insome embodiments, the higher braid angle segment 9604 may have braidangles ranging from about 91° to about 180° (e.g., about 111°, about112°, about 151°, etc.). Higher braid angle segments generally have ahigher PPI and tend to be less porous. Higher PPI can result in asmaller pore size, which can decrease flow into an aneurysm or avascular malformation such as an arterio-venous fistula, which can aidin thrombosis of the aneurysm or vascular malformation.

In some embodiments, the outer diameters of the bulbs 9610 in theradially-expanded configuration are as follows: the distal mediumspherical bulb 9603 has an outer diameter configured to be oversized tothe medium vessel segments such as the proximal M1 segment of the middlecerebral artery (e.g., about 2.75 mm to about 3.25 mm); the middleextra-large spherical bulb 9605 has on outer diameter configured to beoversized by about 25% to about 50% of the largest diameter of one ofthe bifurcation of vessels such as the internal carotid arterybifurcation (e.g., about 5 mm to about 6 mm); and the proximally-nextlarge elongate bulb 9607 has an outer diameter configured to beoversized to the large vessel segments such as the distal supra-clinoidsegment of the internal carotid artery (e.g., about 3.25 mm to about 4mm). Although some example diameters are provided herein, someembodiments of the distal portion 9600 may include diameters of thebulbs 9603, 9605, 9607 in accordance with the values provided aboveand/or diameters that are within about ±5%, about ±10%, about ±15%, orabout ±20% of any such values.

FIG. 6H is a schematic side elevational view of still yet anotherexample embodiment of a distal portion 11300 of a vascular treatmentdevice, for example the distal portion 100 of the device 10, 20, 30, or40. The distal portion 11300 includes, in an expanded state, a pluralityof woven bulbs 11323, 11325, 11327 and necks 11330 including a pluralityof segments having variable pore size along the length of the distalportion 11300. The distal portion 11300 includes, in an expanded state,one generally spherical distal bulb 11323, one generally sphericalproximal bulb 11327, one generally elongate bulb 11325 between the bulb11323 and the bulb 11327, a neck 11324 between the bulbs 11323, 11325, aneck 11326 between the bulbs 11325, 11327, a wide-mouth proximal neck11328, and a wide-mouth distal neck 11322. In some embodiments, thedistal portion 11300 includes a proximal segment 11315 having arelatively low braid angle and relatively higher porosity and a distalsegment 11305 having a relatively low braid angle and relatively higherporosity. The middle segment 11310 includes a first portion 11311 on oneside of the longitudinal axis 4640 having a relatively low braid angleand that is relatively more porous and a second portion 11312 anotherside of the longitudinal axis 4640 having a relatively high braid angleand that is relatively less porous, which may be achieved, for example,by varying speed of rotation of the two hemispheres of the circular horngear or yarn wheel used for braiding the textile structure 11300.

In some embodiments, the speed of rotation of the circular horn gear oryarn wheel for 180° rotation of the yarn wheel, for example the speed ofrotation of the western hemisphere (S_(h-w)) of spindles on the yarnwheel, is different compared to the remaining 180° rotation of the yarnwheel, for example the eastern hemisphere (S_(h-e)) of spindles of theyarn wheel. In certain such embodiments, the pore size can be varied inthe vertical plane on either side of the longitudinal axis 4640. In someembodiments, for example if the speed of rotation in the horizontaldirection of the western hemisphere (S_(h-w)) of the circular horn gearis faster than the speed of motion in the vertical direction (S_(w)) ofthe puller (e.g., when the horn gear ratio (S_(h-w)/S_(v)) is greaterthan 1.0), a high braid angle can be obtained. For example, the higherbraid angle portion 11312 of the middle segment 11310 may have braidangles ranging from about 91° to about 180° (e.g., about 111°, about112°, about 151°, etc.). Higher braid angle segments generally have ahigher PPI and tend to be less porous. Higher PPI can result in asmaller pore size, which can decrease flow into an aneurysm or avascular malformation such as an arterio-venous fistula, which can aidin thrombosis of the aneurysm or vascular malformation. In someembodiments, for example if the speed of rotation in the horizontaldirection of the eastern hemisphere (S_(h-e)) of the circular horn gearis slower than the speed of motion in the vertical direction (S_(w)) ofthe puller (e.g., when the horn gear ratio (S_(h-e)/S_(v)) is less than1.0), a low braid angle can be obtained. For example, the first portion11311 of the middle segment 11310 and the low braid angle segments11305, 11315 may have braid angles ranging from about 0° to about 90°(e.g., about 17°, about 22°, about 45°, etc.).

In some embodiments, for example if the speed of rotation in thehorizontal direction of the circular horn gear (S_(h)) is slower thanthe speed of motion in the vertical direction (S_(w)) of the pullerwherein the speed of rotation of both hemispheres of the circular horngear are the same (S_(h-w)=S_(h-e)) (e.g., when the horn gear ratio(S_(h)/S_(v)) is less than 1.0), a low braid angle can be obtained.Lower braid angle segments generally have lower PPI and tend to be moreporous. Lower PPI can result in a larger pore size, which can allowadequate flow into perforating vessels or small blood vessels adjoiningan aneurysm or a vascular malformation such as an arterio-venousfistula, which can maintain flow in these small but important bloodvessels. Although some example embodiments are provided herein, someembodiments of the distal portion 11300 may include one or more segmentswith variable pore size, combinations thereof, and the like. The bulbshave substantially uniform dimensions or diameters (e.g., within about±5%, about ±10%, about ±15%, or about 20% of each other) such that thedistal portion 11300 may be considered non-tapered. In some embodiments,the force/resistance (e.g., radial force) of the bulbs and/or necks isin a range sufficient to slightly expand the target vessel(s) in therange of about 0% to about 30%, and the shapes of the bulbs and necksare at least partially preserved. In some embodiments, the radial forceof the bulbs and/or necks is in a range sufficient to appose thesidewalls of the vessel to inhibit or prevent an endo-leak, but notsufficient to expand the vessel, and the shapes of the bulbs and necksare no longer preserved such that the shape of the distal portion 11300is substantially tubular, whether tapered or non-tapered, for examplebased on the shape of the target vessel.

FIG. 6I is a schematic side elevational view of another exampleembodiment of a distal portion 11350 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 11350 includes, in an expanded state, a plurality ofwoven bulbs 11353, 11355, 11357 and necks 11370. The distal portion11350 includes, in an expanded state, one generally spherical distalbulb 11353, one generally spherical proximal bulb 11357, one generallyelongate bulb 11355 between the bulb 11353 and the bulb 11357, a neck11364 between the bulbs 11353, 11355, a neck 11366 between the bulbs11355, 11357, a wide-mouth proximal neck 11368, and a wide-mouth distalneck 11362. The distal portion 11350 is aligned along a longitudinalaxis 4640. The longitudinal axis 4640 may run through a center of thedistal portion 11350. The bulb 11355 may be hemi-spherical or generallyhemi-spherical along the longitudinal axis 4640. In some embodiments,the bulb 11355 is hemispherical, trapezoidal, generally hemi-spherical,or generally trapezoidal so that the bulb 11355 appears as a bulge onone side of the distal portion 11350.

In some embodiments, the woven bulb 11355 or a portion thereof (e.g.,one side) that bulges on the side of the distal portion 11350 may bedip-coated or spray coated with a polymer 11360 (e.g., silicone,polyurethane (e.g., Polyslix, available from Duke Extrusion of SantaCruz, Calif.), polyethylene (e.g., Rexell®, available from Huntsman)including low density polyethylene (LDPE), linear low densitypolyethylene (LLDPE), medium density polyethylene (MDPE), and highdensity polyethylene (HDPE), fluoropolymers such as fluorinated ethylenepropylene, PFA, MFA, PVDF, THV, ETFE, PCTFE, ECTFE (e.g., Teflon® FEP,available from DuPont), polypropylene, polyesters including polyethyleneterephthalate (PET), PBT, PETG (e.g., Hytrel®, available from DuPont),PTFE, combination polymer compounds such as thermoplastic polyurethanesand polyether block amides (e.g., Propell™ available from FosterCorporation of Putnam, Conn.), polyether block amides (e.g. Pebax®available from Arkema of Colombes, France, PebaSlix, available from DukeExtrusion of Santa Cruz, Calif.), polyether soft blocks coupled withpolyester hard blocks vinyls such as PVC, PVDC, polyimides (e.g.,polyimides available from MicroLumen of Oldsmar, Fla.), polyamides(e.g., Durethan, available from Bayer, Nylon 12, available from DukeExtrusion of Santa Cruz, Calif.), polycarbonate (e.g., Corethane™,available from Corvita Corp. of Miami, Fla.), styrenics such as PS, SAN,ABS, and HIPS, acetals such as copolymers or homopolymers, PLA, PGA,PLGA, PCL, polyorthoesters, polyanhydrides, and copolymers thereof, hightemperature performance polymers such as PEEK, PES, PPS, PSU, LCP,combinations thereof, and the like). In some embodiments, the polymermay include a radiopaque material (e.g., particles of radiopaquematerial dispersed in the polymer). In some embodiments, masking aportion of the bulb section of the distal portion 11350 during dipcoating or spray coating can inhibit polymer from depositing in the areaof masking. For example, if the distal portion 11350 is dip coated orspray coated while still on a mandrel, the polymer may be inhibited frombeing deposited on the inside of the distal portion 11350, which canmaintain an inner diameter of the distal portion 11350.

In some embodiments, the distal portion 11350 includes plurality ofwoven filaments having a relatively low braid angle, for example rangingfrom about 0° to about 90° (for e.g., about 17°, about 22°, about 45°,etc.). Lower braid angle segments generally have lower PPI and tend tobe more porous. Lower PPI can result in a larger pore size, which canallow adequate flow into perforating vessels or small blood vesselsadjoining an aneurysm or a vascular malformation such as anarterio-venous fistula, which can maintain flow in these small butimportant blood vessels. In some embodiments, the bulb 11355 that is dipcoated or spray coated with a polymer 11360 may be non-porous, which candecrease flow into an aneurysm or a vascular malformation such as anarterio-venous fistula, which can aid in thrombosis of the aneurysm orvascular malformation. The distal portion 11350 may be useful, forexample, for deployment of the non-porous polymer coated bulb 11355across a side-wall basilar arterial brain aneurysm, which can aid inthrombosis of the aneurysm. The deployment of the rest of the distalportion 11350 having a relatively high pore size, across arteries oneither side of the aneurysm can allow blood flow into these arteries,for example the anterior-inferior cerebellar arteries proximally, thebasilar perforators on the other side of the aneurysm, and/or thesuperior cerebellar arteries distally, and which can inhibit or preventocclusion of the basilar perforators and the other branches and/orresulting dysfunction, which could otherwise cause a brainstem stroke,paralysis of the arms, and/or paralysis of the legs. The bulbs havesubstantially uniform dimensions or diameters (e.g., within about ±5%,about ±10%, about ±15%, or about 20% of each other) such that the distalportion 11350 may be considered non-tapered.

FIG. 6J is a schematic side elevational view of still yet anotherexample embodiment of a distal portion 9900 of a vascular treatmentdevice, for example the distal portion 100 of the device 10, 20, 30, or40. The distal portion 9900 includes a plurality of woven bulbs 9910 andwoven necks 9920. The distal portion 9900 includes, in an expandedstate, one generally spherical distal bulb 9903, one generally sphericalproximal bulb 9907, one generally elongate bulb 9905 between the bulb9903 and the bulb 9907, a neck 9914 between the bulbs 9903, 9905, a neck9916 between the bulbs 9905, 9907, a wide-mouth proximal neck 9918 witha diameter 9930, and a wide-mouth distal neck 9912 with a diameter 9925.In some embodiments, the distal portion 9900 includes a plurality ofsegments, at least one of which has a different braid angle. The distalportion 9900 illustrated in FIG. 6J includes a proximal segment 9906having a relatively low braid angle, a middle segment 9904 having arelatively high braid angle, and a distal segment 9902 having arelatively low braid angle. In some embodiments, the lower braid anglesegments 9902, 9906 may have braid angles ranging from about 0° to about90° (e.g., about 17°, about 22°, about 45°, etc.). Lower braid anglesegments generally have lower PPI and tend to be more porous. Lower PPIcan result in a larger pore size, which can allow adequate flow intoperforating vessels or small blood vessels adjoining an aneurysm or avascular malformation such as an arterio-venous fistula, which canmaintain flow in these small but important blood vessels. In someembodiments, the higher braid angle segment 9904 may have braid anglesranging from about 91° to about 180° (e.g., about 111°, about 112°,about 151°, etc.). Higher braid angle segments generally have a higherPPI and tend to be less porous. Higher PPI can result in a smaller poresize, which can decrease flow into an aneurysm or a vascularmalformation such as an arterio-venous fistula, which can aid inthrombosis of the aneurysm or vascular malformation.

In some embodiments, the outer diameters of the bulbs 9910 in theradially-expanded configuration are as follows: the distal extra-largespherical bulb 9603 has an outer diameter configured to be oversized byabout 25% to about 50% to the diameter of the transverse-sigmoidcerebral venous sinus (e.g., about 8 mm to about 12 mm, about 10 mm);the middle elongate bulb 9905 has on outer diameter configured to beoversized by about 25% to about 50% to the diameter of the sigmoidcerebral venous sinus (e.g., about 6 mm to about 10 mm, about 9 mm); andthe proximally-next spherical bulb 9907 has an outer diameter configuredto be oversized to the junction of the sigmoid venous sinus and theinternal jugular vein at the base of skull (e.g., about 6 to about 10mm, about 8 mm). Although some example diameters are provided herein,some embodiments of the distal portion 9900 may include diameters of thebulbs 9903, 9905, 9907 in accordance with the values provided aboveand/or diameters that are within about ±5%, about ±10%, about ±15%, orabout ±20% of any such values, such that the distal portion 9900 may beconsidered to be tapered.

FIG. 7A is a schematic side elevational view of still another exampleembodiment of a distal portion 11000 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 11000 includes a plurality of woven bulbs and wovennecks. The distal portion 11000 includes, in an expanded state, onegenerally spherical distal bulb or central anchor bulb 11012, onegenerally spherical proximal bulb 11014, a neck 11016 between the bulbs11012, 11014, a proximal neck 11017, a distal medial neck 11018, and adistal lateral neck 11019. The bulb 11012 has a diameter D₀. In someembodiments, the neck 11016 between the two bulbs 11012, 11014, theelongate proximal bulb 11014, and the proximal neck 11017 form aproximal segment having a length L₃. The neck 11017 has a wide mouth anda diameter D₃. The distal medial neck 11018 is relatively short, havinga length L₂, and has a diameter D₂. The distal lateral neck 11019 has alength L₁ and has a diameter D₁.

In some embodiments, the distal spherical bulb 11012 has a relativelyhigh braid angle and the rest of the distal portion 11000 has arelatively low braid angle. Lower braid angle segments generally havelower PPI and tend to have relatively high porosity. Lower PPI canresult in a larger pore size, which can allow adequate flow intoperforating vessels or small blood vessels adjoining an aneurysm or avascular malformation such as an arterio-venous fistula, which canmaintain flow in these small but important blood vessels. In someembodiments, the proximal segment has a relatively low braid angle.Higher braid angle segments generally have a higher PPI and tend to haverelatively low porosity. Higher PPI can result in a smaller pore size,which can decrease flow into an aneurysm or a vascular malformation suchas an arterio-venous fistula, which can aid in thrombosis of theaneurysm or vascular malformation.

In some embodiments, the outer diameters of the bulbs and necks in theradially-expanded configuration are as follows: D₁ is configured to beoversized to the medium vessel segments such as the proximal M1 segmentof the middle cerebral artery (e.g., about 2.75 mm to about 3.25 mm); D₂is configured to be oversized to the medium vessel segments such as theproximal A1 segment of the anterior cerebral artery (e.g., about 2.25 mmto about 2.75 mm); D₀ is configured to be oversized by about 25% toabout 50% of the largest diameter of one of the bifurcation of vesselssuch as the internal carotid artery bifurcation (e.g., about 5 mm toabout 6 mm); and D₃ is configured to be oversized to the large vesselsegments such as the distal supra-clinoid segment of the internalcarotid artery (e.g., about 3.25 mm to about 4 mm). Although someexample diameters are provided herein, some embodiments of the distalportion 11000 may include diameters of the bulbs 11012, 11014 and necks11016, 11017, 11018, 11019 in accordance with the values provided aboveand/or diameters that are within about ±5%, about ±10%, about ±15%, orabout ±20% of any such values.

Although the necks 11017, 11018, 11019 are illustrated in FIG. 7A asbeing in the same plane (e.g., the plane of the page or the screen), thenecks 11017, 11018, 11019 may be in different planes, for example basedon certain vasculature. In contrast to pure balls deployed atbifurcations, necks 11017, 11018, 11019 can preserve anatomy for laterprocedures. For example, a thrombectomy device could be inserted throughthe neck 11017 and then into the vessel in which the neck 11018 residesand/or in which the neck 11019 resides. Certain distal portionsdescribed herein can be described as an endoprosthesis, a stent, etc. Aproximal portion can be attached to endoprosthesis through detachablejoint (e.g., Guglielmi electrolytic detachment, mechanical detachment,etc.).

FIG. 7B is a schematic side elevational view of still yet anotherexample embodiment of a distal portion 11100 of a vascular treatmentdevice, for example the distal portion 100 of the device 10, 20, 30, or40. The distal portion 11100 includes a plurality of woven bulbs andwoven necks. The distal portion 11100 includes, in an expanded state,one generally spherical or ovoid proximal bulb 11105 having a diameterD₀, one generally elongate distal bulb 11110, a neck 11115 between thebulbs 11105, 11110, a wide-mouth distal neck 11130 having a diameter D₃,a proximal medial neck 11125, and a proximal lateral neck 11120. In someembodiments, the neck 11115, the elongate distal bulb 11110, and thedistal neck 11130 form a distal segment having a length L₃. The proximalmedial neck 11125 is short, having a length L₂, and has a narrow mouthhaving a diameter D₂. The proximal lateral neck 11120 is short, having alength L₁, and has a narrow mouth having a diameter D₁.

In some embodiments, the distal portion 11100 includes a proximalspherical or ovoid bulb 11105, the elongate distal bulb 11110, and theneck 11115 between the bulbs 11105, 11110 each having a relatively highbraid angle, and segments including the rest of the woven necks have arelatively low braid angle. For example, the lower braid angle segmentsmay have braid angles ranging from about 0° to about 90° (e.g., about17°, about 22°, about 45°, etc.). Lower braid angle segments generallyhave lower PPI and tend to have relatively high porosity. Lower PPI canresult in a larger pore size, which can allow adequate flow intoperforating vessels or small blood vessels adjoining an aneurysm or avascular malformation such as an arterio-venous fistula, which canmaintain flow in these small but important blood vessels. For example,the higher braid angle segment may have braid angles ranging from about91° to about 180° (e.g., about 111°, about 112°, about 151°, etc.).Higher braid angle segments generally have a higher PPI and tend to haverelatively low porosity. Higher PPI can result in a smaller pore size,which can decrease flow into an aneurysm or a vascular malformation suchas an arterio-venous fistula, which can aid in thrombosis of theaneurysm or vascular malformation.

In some embodiments, the outer diameters of the bulbs and necks in theradially-expanded configuration are as follows: the proximal lateralneck 11120 has an outer diameter D₁ configured to be oversized to thelarge vessel segments such as the common iliac artery (e.g., about 8 mmto about 12 mm); the proximal medial neck 11125 has an outer diameter D₂configured to be oversized to the large vessel segments such as thecommon iliac artery (e.g., about 8 mm to about 12 mm); the proximalspherical bulb 11105 has on outer diameter D₀ configured to be oversizedby about 20% to about 50% of the largest diameter of abdominal aorta(e.g., about 10 mm to about 40 mm, about 18 mm to about 22 mm); and thedistal segment D₃ has an outer diameter configured to be oversized byabout 20% to about 50% to the large vessel segments such as thesupra-renal or infra-renal abdominal aorta (e.g., about 10 mm to about40 mm, about 18 mm to about 22 mm). The bulbs 11105, 11110 the necks11115, 11120, 11125, and the distal neck 11130 can provide good wallapposition, which can inhibit or prevent the risk of an endo-leak intothe aneurysm. The bulbs 11105, 11110 have substantially uniformdimensions or diameters (e.g., within about ±5%, about ±10%, about ±15%,or about 20% of each other) such that the distal portion 11100 may beconsidered non-tapered. Although some example diameters are providedherein, some embodiments of the distal portion 11100 may includediameters of the bulbs 11105, 11110 and necks 11115, 11120, 11125, 11130in accordance with the values provided above and/or diameters that arewithin about ±5%, about ±10%, about ±15%, or about ±20% of any suchvalues.

Although the necks 11120, 11125, 11130 are illustrated in FIG. 7B asbeing in the same plane (e.g., the plane of the page or the screen), thenecks 11120, 11125, 11130 may be in different planes, for example basedon certain vasculature. In contrast to endovascular or surgicalendoprostheses that require deployment through both common femoralarteries or both common iliac arteries, the example embodimentillustrated in FIG. 7B can be deployed through one artery such as acommon femoral artery. Certain distal portions described herein can bedescribed as an endoprosthesis, a stent, etc. A proximal portion can beattached to endoprosthesis through detachable joint (e.g., Guglielmielectrolytic detachment, mechanical detachment, etc.).

FIG. 7C is a schematic side elevational view of another exampleembodiment of a distal portion 11400 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 11400 includes a plurality of woven bulbs 11405, 11415,11425, 11435, a woven neck 11422 between the bulbs 11405, 11415, a wovenneck 11424 between the bulbs 11415, 11425, a woven neck 11426 betweenthe bulbs 11425, 11435, a woven proximal neck 11420, and a woven distalneck 11428. In some embodiments, the distal portion 11400 includes, inan expanded state, two ovoid or ellipsoid or oblate spheroid outer bulbs11405, 11435 and two ovoid or ellipsoid or oblate spheroid inner bulbs11415, 11425, wide-mouthed necks 11422, 11424, 11426 between the bulbs11405, 11415, a proximal narrow-mouthed neck 11420 attached to theproximal portion 200 at a joint 300, and a distal narrow-mouthed neck11428. In some embodiments, the bulbs 11405, 11415, 11425, 11435comprise ellipsoids or oblate spheroids in which the diameter of thepolar axis is shorter than the diameter of the equatorial axis (e.g.,flattened discs stacked proximate to each other). The necks 11422,11424, 11426 between the bulbs 11405, 11415, 11425, 11435 may beconnected at the polar axis rather than being connected at theequatorial axis.

In some embodiments, the distal portion 11400 includes a plurality ofsegments, at least one of which has a different braid angle. The distalportion 11400 illustrated in FIG. 7C includes a middle segmentcomprising the wide-mouthed woven neck 11424 between the two inner bulbs11415, 11425. The middle segment has a relatively low braid angle, andthe woven necks 11420, 11422, 11426, 11428 and the woven bulbs 11405,11415, 11425, 11435 have a relatively high braid angle. In someembodiments, the lower braid angle segment may have braid angles rangingfrom about 0° to about 90° (e.g., about 17°, about 22°, about 45°,etc.). Lower braid angle segments generally have lower PPI and tend tohave relatively high porosity. Lower PPI can result in lower chronicoutward force (COF), which can cause flow disruption within a fistula oran abnormal communication between two hollow cavities by forming a softscaffold within the fistula or abnormal communication between two hollowcavities, which can aid in thrombosis of the fistula or abnormalcommunication between two hollow cavities. In some embodiments, thehigher braid angle segment(s) (e.g., proximal and distal to the lowerbraid angle segment as illustrated in FIG. 7C) may have braid anglesranging from about 91° to about 180° (e.g., about 111°, about 112°,about 151°, etc.). Higher braid angle segments generally have a higherPPI and tend to have relatively low porosity. Higher PPI can result in asmaller pore size, which can decrease flow into a fistula or abnormalcommunication between two hollow cavities, which can aid in thrombosisof the fistula or abnormal communication between two hollow cavities. Arelatively low pore size can serve as a filter to inhibit or prevent athrombus formed within the fistula or abnormal communication between twohollow cavities from forming emboli or small debris that could otherwisebreak off and enter the normal vasculature. Referring again to FIGS.4I-4K, the neck 11424 having a high pore size may have a variable lengthand/or a variable diameter, which can allow the neck 11424 to conform tothe dimensions of a fistula or abnormal communication between two hollowcavities, which can provide good wall apposition and/or aid inthrombosis of the fistula or abnormal communication between two hollowcavities. Although some examples of fistulas are provided herein, thedistal portion 11400 illustrated in FIG. 7C and the like may be usefulin any fistula or abnormal communication between two hollow cavities inthe body.

In some embodiments, the outer diameters of the woven bulbs in theradially-expanded configuration are as follows: the two inner ellipsoidor oblate spheroid bulbs 11415 and 11425 have an outer diameterconfigured to be oversized between about 50% and about 75% to the widthof the orifice of the fistula or abnormal communication between twohollow cavities (e.g., between about 2 mm and about 16 mm, about 8 mm);the two outer ellipsoid or oblate spheroid bulbs 11405 and 11435 have anouter diameter configured to be oversized between about 25% and about50% to the width of the orifice of the fistula or abnormal communicationbetween two hollow cavities (e.g., between about 2 mm and about 16 mm,about 8 mm); the middle segment neck 11424 has an outer diameterconfigured to be oversized between about 10% and about 25% to the widthof the orifice of the fistula or abnormal communication between twohollow cavities (e.g., between about 2 mm and about 16 mm, about 8 mm);and the middle segment neck 11424 has a length configured to beoversized between about 10% and about 25% to the length of the orificeof the fistula or abnormal communication between two hollow cavities(e.g., between about 2 mm and about 26 mm, between about 4 mm and about8 mm, about 6 mm). Although some example diameters are provided herein,some embodiments of the distal portion 11400 may include diameters ofthe woven necks 11420, 11422, 11424, 11426, 11428, diameters of thewoven bulbs 11405, 11415, 11425, 11435, and/or length of the woven neck11424 in accordance with the values provided above and/or diameters thatare ±5%, ±10%, ±15%, or ±20% of any such values.

FIG. 7D is a schematic side elevational view of yet another exampleembodiment of a distal portion 11600 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 11600 includes a plurality of woven bulbs 11610 and wovennecks 11620. In some embodiments, the distal portion 11600 includes, inan expanded state, three ovoid or ellipsoid or spheroid woven bulbs11610 including a distal bulb 11625, a middle bulb 11615, and a proximalbulb 11605, a wide-mouthed neck 11604 between the bulbs 11625, 11615, awide-mouthed neck 11602 between the bulbs 11615, 11605, a proximalnarrow-mouthed neck that is attached to the proximal portion at joint300, and a distal narrow-mouthed neck 11606. In some embodiments, thebulbs 11610 are ellipsoids or oblate spheroids having a polar axisdiameter that is smaller than an equatorial axis diameter (e.g.,flattened discs stacked proximate to each other). The necks 11602, 11604between the bulbs 11610 may be connected at the polar axis rather thanthe equatorial axis. In some embodiments, the distal portion 11600includes a plurality of segments, at least one of which has a differentbraid angle. The distal portion 11600 illustrated in FIG. 7D includes aproximal segment, comprising the proximal bulb 11605, which is attachedto the proximal portion 200 at the joint 300, that has a relatively highbraid angle and a distal segment, comprising the middle bulb 11615, thedistal bulb 11625 and the necks 11602, 11604, 11606, that has arelatively low braid angle. In some embodiments, the lower braid anglesegment may have braid angles ranging from about 0° to about 90° (e.g.,about 17°, about 22°, about 45°, etc.). Lower braid angle segmentsgenerally have lower PPI and tend to have relatively high porosity.Lower PPI can result in a larger pore size, which can cause flowdisruption within an aneurysm by forming a soft scaffold within theaneurysm and aid in the thrombosis of the aneurysm. In some embodiments,the higher braid angle segment may have braid angles ranging from about91° to about 180° (e.g., about 111°, about 112°, about 151°, etc.).Higher braid angle segments generally have a higher PPI and tend to haverelatively low porosity. Higher PPI can result in a smaller pore size,which can decrease flow into an aneurysm, which can aid in thrombosis ofthe aneurysm. A relatively low pore size can serve as a filter toinhibit or prevent a thrombus formed within the aneurysm from breakingoff (e.g., as emboli or small debris) and entering the normalvasculature.

In some embodiments, the outer diameters of the bulbs 11610 in theradially-expanded configuration are as follows: the distal oval orellipsoid bulb 11625 has an outer diameter configured to be undersizedbetween about 25% to about 50% of the largest diameter of theventricular wall aneurysm within the heart (e.g., about 5 mm to about7.5 mm for a ventricular wall aneurysm with the largest diameter about10 mm); the middle oval or ellipsoid bulb 11615 and the proximal oval orellipsoid bulb 11605 have an outer diameter configured to be oversizedbetween about 50% to about 75% of the diameter of the neck of theventricular wall aneurysm such that the proximal bulb 11605 is anchoredwithin the aneurysm with limited risk of the bulb 11605 falling out ofthe aneurysm into the ventricle of the heart. The proximal oval orellipsoid bulb 11605 and the middle oval or ellipsoid bulb 11615 mayhave an outer diameter that is no greater than the largest diameter ofthe ventricular aneurysm such that there is no or limited significantoutward force on the aneurysm wall that could otherwise cause a rupture(e.g., about 7.5 mm to about 8.75 mm for a ventricular wall aneurysmwith the largest diameter about 10 mm having a neck with a diameter ofabout 5 mm). Although some example diameters are provided herein, someembodiments of the distal portion 11600 may include diameters of thebulbs 11625, 11615, 11605 in accordance with the values provided aboveand/or diameters that are within about ±5%, about ±10%, about ±15%, orabout ±20% of any such values, such that the distal portion 11600 may beconsidered to be tapered.

FIG. 7E is a schematic side elevational view of still another exampleembodiment of a distal portion 11500 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 11500 includes a plurality of woven bulbs 11510 and wovennecks 11520. In some embodiments, the distal portion 11500 includes, inan expanded state, four ovoid or ellipsoid or spheroid woven bulbs 11510including a distal bulb 11518, a second bulb 11516, a third bulb 11514,and a proximal bulb 11512, wide-mouthed necks 11520 between the bulbs11510, a proximal narrow-mouthed neck 11522 that is attached to theproximal portion 200 at joint 300, and a distal narrow-mouthed neck 65.In some embodiments, the bulbs 11510 comprise ellipsoids or oblatespheroids having a polar axis diameter that is shorter than anequatorial axis diameter (e.g., flattened discs stacked proximate toeach other). The necks 11520 between the bulbs 11510 may be connected atthe polar axis rather than the equatorial axis. In some embodiments, thedistal portion 11500 includes a plurality of segments, at least one ofwhich has a different braid angle. The distal portion 11500 illustratedin FIG. 7E includes a proximal segment, comprising the proximal twobulbs 11512, 11514 and the proximal neck 11522, that has a relativelyhigh braid angle and a distal segment, comprising segments including therest of the distal portion 11500 including the distal two bulbs 11516,11518 and the distal neck 65, that has a relatively low braid angle. Insome embodiments, the lower braid angle segment may have braid anglesranging from about 0° to about 90° (e.g., about 17°, about 22°, about45°, etc.). Lower braid angle segments generally have lower PPI and tendto have relatively high porosity. Lower PPI can result in a larger poresize, which can cause flow disruption within an aneurysm by forming asoft scaffold within the aneurysm or hollow cavity and can aid in thethrombosis of the aneurysm or hollow cavity. In some embodiments, thehigher braid angle segment may have braid angles ranging from about 91°to about 180° (e.g., about 111°, about 112°, about 151°, etc.). Higherbraid angle segments generally have a higher PPI and tend to haverelatively low porosity. Higher PPI can result in a smaller pore size,which can decrease flow into an aneurysm or hollow cavity, which can aidin thrombosis of the aneurysm or the hollow cavity. A relatively lowpore size can serve as a filter to inhibit or prevent a thrombus formedwithin the aneurysm from breaking off (e.g., as emboli or small debris)and entering the normal vasculature.

In some embodiments, the outer diameters of the bulbs 11510 in theradially-expanded configuration are as follows: the distal ellipsoid oroblate spheroid bulb 11518 has an outer diameter configured to beundersized between about 25% to about 50% to the width of the leftatrial appendage within the heart (e.g., between 8 mm to about 35 mm,about 17 mm); the second ellipsoid or oblate spheroid bulb 11516 and thethird ellipsoid or oblate spheroid bulb 11514 have an outer diameterconfigured to be oversized between about 25% to about 50% to the widthof the left atrial appendage within the heart (e.g., between 8 mm toabout 35 mm, about 17 mm). The proximal ellipsoid or oblate spheroidbulb 11512 has an outer diameter configured to be oversized betweenabout 50% to about 75% to the width of the orifice of the left atrialappendage within the heart (e.g., between 5 mm to about 20 mm, about 10mm). The length of the distal portion 11500 along the longitudinal axis,illustrated in FIG. 7E with a dashed line, is between 13 mm and about 45mm (e.g., about 26 mm). Although some example diameters are providedherein, some embodiments of the distal portion 11600 may includediameters of the bulbs 11518, 11516, 11514, 11512 in accordance with thevalues provided above and/or diameters that are within about ±5%, about±10%, about ±15%, or about ±20% of any such values, such that the distalportion 11500 may be considered to be tapered.

FIG. 8A is a schematic side perspective view of an example embodiment ofa braiding device or carrier braider 150. The braiding device 150includes a yarn wheel or braid carrier mechanism or circular horn gear152 and a plurality of spindles 153 and individual carriers 155. Aspindle 153 is a stick on the circular horn gear 152. A spool 154 is ahollow device that fits onto a spindle 153 and includes filaments 156wound around it. An individual carrier 155 includes a spindle 153 and aspool 154 on the spindle 153. The terms spindle, spool, and individualcarrier may be used interchangeably depending on context. The individualcarriers 155 include spools 154 including filaments 156 that are woventogether to form the textile structure 158 of the distal portion 100.The filaments 156 each extend from an individual carrier 155 to a ringor vertical puller 161 over a mandrel 162 and are braided around themandrel 162 by spinning the circular horn gear 152, spinning thespindles 153, and pulling the ring 161 away from the circular horn gear152. Although some examples of the carrier braider 150 with 18 spindles153 or individual carriers 155 are provided herein, some embodiments ofthe carrier braider 150 may include 6 to 144 spindles 153 or individualcarriers 155 in accordance with the values provided above and/or carrierbraiders 150 that have 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, etc.spindles 153 or individual carriers 155. As the textile structure 158 iswoven at preform point 160, the textile structure 158 advances in thedirection of the arrow 164. The circular horn gear 152 spins in thedirection of the arrows 166, and the spindles 153, which are part of theindividual carriers 154, rotate within the circular horn gear 154 tocreate the desired braiding pattern.

In some embodiments, the mandrel 162 comprises a rod or tube (e.g.,comprising stainless steel) having a uniform outer diameter. In someembodiments, the outer diameter of the mandrel 162 is between about 4 mmand about 9 mm (e.g., about 6 mm, about 6.5 mm). In some embodiments,the outer diameter of the mandrel 162 is between about 33% and about200% larger than the largest bulb that the distal portion 100 willinclude. In some embodiments, the smaller the diameters or widths of thefilaments, the more oversizing the mandrel 162 may reduce defects atlater stages of fabrication.

FIG. 8B is a schematic diagram illustrating an example setup of a braidcarrier mechanism 2600. The yarn wheel 2600 includes spindles 153without spools 155 or without forming individual carriers 154 andspindles 153 with spools 155 including filaments 156 together formingindividual carriers 154. In FIG. 8B, the half circles with dark shadingindicate individual carriers 155 including spools 154 including shapememory filaments, the half circles with hatched shading indicateindividual carriers 155 including spools 154 including radiopaquefilaments, and the half circles with no shading indicate spindleswithout spools 154 or filaments 156. The yarn wheel 2600 illustrated inFIG. 8B includes 144 spindles 153 or individual carriers 154 with 72outer spindles labeled 1 o through 72 o and 72 inner spindles labeled 1i through 72 i. One outer spindle and one inner spindle form a “doublespindle pair.” The spindles 154 spin in the direction indicated by thearrow proximate to the shading. In the arrangement illustrated in FIG.8B, spindles 1 o, 2 i, 4 o, 5 i, 7 o, 8 i, 10 o, 11 i, 13 o, 14 i, 16 o,17 i, 19 o, 20 i, 22 o, 23 i, 25 o, 26 i, 28 o, 29 i, 31 o, 32 i, 34 o,35 i, 37 o, 38 i, 40 o, 41 i, 43 o, 44 i, 46 o, 47 i, 49 o, 50 i, 52 o,53 i, 55 o, 56 i, 58 o, 59 i, 61 o, 62 i, 64 o, 65 i, 67 o, 68 i, 70 o,and 71 i include spools including shape-memory material (e.g., 48 of thefilaments 156 comprise shape-memory material) and the remaining spindlesare empty. None of the spindles includes radiopaque material.

Certain patterns can be discerned based on spindle arrangement and spindirection. For example, in the braid carrier mechanism 2600 of FIG. 8B,spindles 1 o and 2 i spin in opposite directions such that duringweaving, filaments extending from the spools 154 on the spindles 1 o and21 will cross over each other, spindles 2 i and 4 o spin in the samedirection such that during weaving, filaments extending from the spools154 on the spindles 2 i and 4 o cross under each other, and spindles 4 oand Si spin in opposite directions such that during weaving, filamentsextending from the spools 154 on the spindles 4 o and Si cross over eachother, such that a one-over-one-under-one braiding pattern for the shapememory filaments can be discerned by analysis of the braid carriermechanism 2600 of FIG. 8B.

FIG. 8C is a schematic diagram illustrating a magnified view of threepairs of spindles 1 o, 1 i, 2 o, 2 i, 3 o, 3 i in the example setup ofthe braid carrier mechanism 2600 of FIG. 8B. In FIGS. 8B and 8C, thepattern of the filaments 156 is symmetrical because there is a spool 154including a shape memory filament in the outer spindle 1 o paired withan empty inner spindle 1 i, followed by an empty outer spindle 2 opaired with a spool 154 including a shape memory filament in the innerspindle 21, and then followed by an empty double spindle pair 3 o, 31,and then the pattern repeats itself in the pairs of spindles 4 o, 4 i, 5o, 5 i, 6 o, 6 i and so on. Symmetrical patterns of filaments 156 may beassociated with a uniform pore size. Filament adjacency may be definedas the angular circumference of the yarn wheel 152, which is 360°,divided by the number of filament spools. For example, if the yarn wheel152 includes 48 filament spools, the filament adjacency would be360°/48=7.5°. Filament adjacency may be used, for example, to helpcontrol symmetry of patterns. In some embodiments, the pattern of spoolsincluding the filaments 156 on spindles 153 can be asymmetrical, whichcan lead to varying pore size along the braid axis.

In some embodiments, placement of spools 154 or lack of placement ofspools 154 including filaments 156 on spindles 153 adjacent to eachother can affect properties of the textile structure 158 such as poresize. Spindle adjacency may be defined as the angular circumference ofthe yarn wheel 152, which is 360°, divided by the number of doublespindle pairs. For example, if the yarn wheel 152 includes 144 spindles153 or 72 double spindle pairs, the spindle adjacency would be360°/72=5°. In some embodiments, each double spindle pair that is emptycreates a pore. Increasing the number of empty spindles 154 adjacent toeach other (e.g., one, two, or more spindle pairs adjacent to eachother) may increase the size of the pore. FIG. 8D is a photographillustrating a plurality of filaments 156 being braided on a mandrel 162using a braiding device or carrier braider 150. In FIG. 8D, thereflectivity of the radiopaque filaments 156 contrast with thereflectivity of the shape-memory filaments 156, creating a crisscrossappearance of the tubular textile structure 158. In some embodiments,the placement of spools 154 including filaments 156 of a particular typeof material on spindles 153 adjacent to each other can affect propertiessuch as visibility under x-ray. Filament material adjacency may bedefined as the angular circumference of the yarn wheel 152, which is360°, divided by the number of filament spools of a particular type ofmaterial. For example, if the yarn wheel 152 includes 12 filament spoolsincluding radiopaque filaments evenly spaced from each other, thefilament material adjacency would be 360°/12=30°. Filament materialadjacency may be used to help control helical crossing points that arevisible under x-ray. The arrangement of the filaments 156 illustrated inFIG. 8B, in which some radiopaque filaments 156 are circumferentiallyadjacent or proximate to each other, groups some radiopaque filaments toform an intertwining band of radiopaque material. A band of radiopaquematerial, for example as opposed to evenly distributed radiopaquematerial, may be easier to identify during fluoroscopy, particularly ifthe filaments are small.

In some embodiments, the radiopaque material includes metals or alloysincluding, but not limited to, iridium, platinum, tantalum, gold,palladium, tungsten, tin, silver, titanium, nickel, zirconium, rhenium,bismuth, molybdenum, combinations thereof, and the like, which canincrease visibility of the distal portion 100 under fluoroscopy duringinterventional procedures. The radiopaque material may be part of analloy (e.g., 92% platinum and 8% tungsten alloy), part of a core orcladding around a core (e.g., nitinol with a tungsten core),combinations thereof, and the like.

FIG. 8E is a schematic side elevational view of still another exampleembodiment of a distal portion 2800 of a vascular treatment device, forexample the distal portion 100 of the device 10, 20, 30, or 40. Thedistal portion 2800 includes, in an expanded state, a proximal neck 70and a cylindrical wide-mouthed textile structure 75 includingshape-memory filaments and radiopaque filaments. The textile structure75 expands radially outwardly from proximal to distal, and then stays atthe larger diameter until the distal end. FIG. 8F is a schematic sideelevational view of the distal portion 2800 of FIG. 8E, illustrating anexample pattern of radiopaque filaments, for example under x-ray. Thedistal portion 2800 includes, in an expanded state, a single radiopaquefilament 2820 that is interlaced in the form a single sine wave thatappears like a “simple helix” at least under x-ray. The pattern ofradiopacity can allow an operator of a device comprising the distalportion 2800 to visualize and identify the distal portion 2800 at leastunder x-ray. In some embodiments, the single simple helix includestroughs and peaks, for example at the sides of the distal portion 2800that the simple helix at least partially creates. In FIG. 8F, thehelical intersection points 2825, 2835, 2845, 2855 are substantiallyuniformly spaced by distances 2830, 2840, 2850, which can allow thedistal portion 2800 to serve as an angiographic measurement ruler. Forexample, the distances 2830, 2840, 2850 can help an operator to measurethe length of blood clots, the neck of an aneurysm, the length of astenosis, etc. In some embodiments, a distance 2860 between points 2855,2856 at least partially along the proximal neck 70 has differentdimensions than the simple helix in the rest of the larger diameter partof the distal portion 2800, which may serve as an identifier of theproximal neck 70 beyond which the distal portion 2800 should not bedeployed.

FIG. 8G is a schematic diagram illustrating an example setup of a braidcarrier mechanism 2870 for forming the distal portion 2800 of FIG. 8E.In FIG. 8G, the half circles with dark shading indicate individualcarriers 155 including spools 154 including shape memory filaments 156,the half circles with hatched shading indicate individual carriers 155including spools 154 including radiopaque filaments 156, and the halfcircles with no shading indicate spindles without spools 154 orfilaments 156. In the arrangement illustrated in FIG. 8G, spindles 2 i,4 o, 5 i, 7 o, 8 i, 10 o, 11 i, 13 o, 14 i, 16 o, 17 i, 19 o, 20 i, 22o, 23 i, 25 o, 26 i, 28 o, 29 i, 31 o, 32 i, 34 o, 35 i, 37 o, 38 i, 40o, 41 i, 43 o, 44 i, 46 o, 47 i, 49 o, 50 i, 52 o, 53 i, 55 o, 56 i, 58o, 59 i, 61 o, 62 i, 64 o, 65 i, 67 o, 68 i, 70 o, 71 i include spools154 including shape-memory material (e.g., 47 of the filaments 156comprise shape-memory material), the spindle 1 o includes a spoolincluding radiopaque material (e.g., 1 of the 48 filaments 156 comprisesradiopaque material), and the remaining spindles 153 are empty. Thebraid carrier mechanism 2870 setup illustrated in FIG. 8G can generate apattern of radiopacity described with respect to FIG. 8F, for example asingle sine wave or simple helix pattern. The radiopaque filament 156forms a sine wave having a spindle adjacency of about 5° (360°/72), afilament adjacency of about 7.5° (360°/48), and a radiopaque filamentmaterial adjacency of about 360° (360°/1). Although some examples of thecarrier braider 150 with 48 spindles 153 or individual carriers 155 areprovided herein, some embodiments of the carrier braider 150 may include6 to 144 spindles 153 or individual carriers 155 in accordance with thevalues provided above and/or carrier braiders 150 that have 6, 12, 24,36, 48, 60, 72, 84, 96, 120, 144, etc. spindles 153 or individualcarriers 155, and the number and positioning of radiopaque filaments 156can remain as provided in the example braid carrier mechanism 2870setup.

FIG. 8H is a schematic side elevational view of another exampleembodiment of a distal portion 2900 of a vascular treatment deviceillustrating an example pattern of radiopaque filaments, for exampleunder x-ray. The distal portion 2900 may be the distal portion 100 ofthe device 10, 20, 30, or 40. The distal portion 2900 includes, in anexpanded state, a proximal neck 70 and a cylindrical wide-mouthedtextile structure 75 including shape-memory filaments and radiopaquefilaments. The textile structure 75 expands radially outwardly fromproximal to distal, and then stays at the larger diameter until thedistal end. The distal portion 2900 includes, in an expanded state, tworadiopaque filaments 2911, 2913 that are interlaced in the form a doublesine wave like a “double helix” at least under x-ray. The pattern ofradiopacity can allow an operator of a device comprising the distalportion 2900 to visualize and identify the distal portion 2900 at leastunder x-ray. In some embodiments, the double helix includes troughs andpeaks, for example at the sides of the distal portion 2900 that thedouble helix at least partially create. In FIG. 8H, the helicalintersection points 2925, 2935, 2945, 2955, 2965, 2975 are substantiallyuniformly spaced by distances 2930, 2940, 2950, 2960, 2970, 2980, whichcan allow the distal portion 2900 to serve as an angiographicmeasurement ruler. For example, the distances 2930, 2940, 2950, 2960,2970, 2980 can help an operator to measure the length of blood clots,the neck of an aneurysm, the length of a stenosis, etc. In someembodiments, distances between helical intersection points in theproximal neck 70 has different dimensions than the double helix in therest of the large diameter part of the distal portion 2900, which mayserve as an identifier of the proximal neck 70 beyond which the distalportion 2900 should not be deployed.

FIG. 8I is a schematic diagram illustrating an example setup of a braidcarrier mechanism 2990 for forming the distal portion 2800 of FIG. 8H.In FIG. 8I, the half circles with dark shading indicate individualcarriers 155 including spools 154 including shape memory filaments 156,the half circles with hatched shading indicate individual carriers 155including spools 154 including radiopaque filaments 156, and the halfcircles with no shading indicate spindles without spools 154 orfilaments 156. In the arrangement illustrated in FIG. 8I, spindles 2 i,4 o, 5 i, 7 o, 8 i, 10 o, 11 i, 13 o, 14 i, 16 o, 17 i, 19 o, 20 i, 22o, 23 i, 25 o, 26 i, 28 o, 29 i, 31 o, 32 i, 34 o, 35 i, 38 i, 40 o, 41i, 43 o, 44 i, 46 o, 47 i, 49 o, 50 i, 52 o, 53 i, 55 o, 56 i, 58 o, 59i, 61 o, 62 i, 64 o, 65 i, 67 o, 68 i, 70 o, 71 i include spools 154including shape-memory material (e.g., 46 of the 48 filaments 156comprise shape-memory material), the spindles 1 o and 37 o includespools 154 including radiopaque material (e.g., 2 of the 48 filaments156 comprise radiopaque material), and the remaining spindles are empty.The braid carrier mechanism 2990 setup illustrated in FIG. 8I cangenerate a pattern of radiopacity described with respect to FIG. 8H, forexample a double sine wave or double helix pattern. The radiopaquefilaments 156 form two sine waves having a spindle adjacency of about 5°(360°/72), a filament adjacency of about 7.5° (360°/48), and aradiopaque filament material adjacency of about 180° (360°/2). Althoughsome examples of the carrier braider 150 with 48 spindles 153 orindividual carriers 155 are provided herein, some embodiments of thecarrier braider 150 may include 6 to 144 spindles 153 or individualcarriers 155 in accordance with the values provided above and/or carrierbraiders 150 that have 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, etc.spindles 153 or individual carriers 155, and the number and positioningof radiopaque filaments 156 can remain as provided in the example braidcarrier mechanism 2990 setup.

FIG. 8J is a schematic side elevational view of yet another exampleembodiment of a distal portion 4000 of a vascular treatment deviceillustrating an example pattern of radiopaque filaments, for exampleunder x-ray. The distal portion 4000 may be the distal portion 100 ofthe device 10, 20, 30, or 40. The distal portion 4000 includes, in anexpanded state, a proximal neck 70 and a cylindrical wide-mouthedtextile structure 75 including shape-memory filaments and radiopaquefilaments. The textile structure 75 expands radially outwardly fromproximal to distal, and then stays at the larger diameter until thedistal end. The distal portion 4000 includes, in an expanded state, twopairs of radiopaque filaments 4011, 4013 and 4015, 1017 that areinterlaced in the form a paired double sine wave like a “dual doublehelix” at least under x-ray. The pattern of radiopacity can allow anoperator of a device comprising the distal portion 4000 to visualize andidentify the distal portion 4000 at least under x-ray. In someembodiments, the dual double helix includes troughs and peaks, forexample at the sides of the distal portion 4000 that the dual doublehelix at least partially create. In FIG. 8J, the helical intersectionpoints 4025, 4035, 4045, 4055 are substantially uniformly spaced bydistances 4030, 4040, 4050, which can allow the distal portion 4000 toserve as an angiographic measurement ruler. For example, the distances4030, 4040, 4050 can help an operator to measure the length of bloodclots, the neck of an aneurysm, the length of a stenosis, etc. In someembodiments, a distance 4060 between points 4055, 4065 at leastpartially along the proximal neck 70 has different dimensions than thedual double helix in the rest of the large diameter part of the distalportion 4000, which may serve as an identifier of the proximal neck 70beyond which the distal portion 4000 should not be deployed.

FIG. 8K is a schematic diagram illustrating an example setup of a braidcarrier mechanism 4080 for forming the distal portion 4000 of FIG. 8J.In FIG. 8K, the half circles with dark shading indicate individualcarriers 155 including spools 154 including shape memory filaments 156,the half circles with hatched shading indicate individual carriers 155including spools 154 including radiopaque filaments 156, and the halfcircles with no shading indicate spindles without spools 154 orfilaments 156. In the arrangement illustrated in FIG. 8K, spindles 2 i,4 o, 5 i, 7 o, 8 i, 10 o, 11 i, 13 o, 14 i, 16 o, 17 i, 19 o, 20 i, 22o, 23 i, 25 o, 26 i, 28 o, 29 i, 31 o, 32 i, 34 o, 38 i, 40 o, 41 i, 43o, 44 i, 46 o, 47 i, 49 o, 50 i, 52 o, 53 i, 55 o, 56 i, 58 o, 59 i, 61o, 62 i, 64 o, 65 i, 67 o, 68 i, 70 o include spools 154 includingshape-memory material (e.g., 44 of the 48 filaments 156 compriseshape-memory material), the spindles 1 o, 35 i, 37 o, 71 i includespools 154 including radiopaque material (e.g., 4 of the 48 filaments156 comprise radiopaque material), and the remaining spindles are empty.The braid carrier mechanism 4080 setup illustrated in FIG. 8K cangenerate a pattern of radiopacity described with respect to FIG. 8J, forexample pairs of double sine waves or a dual double helix pattern.Although some examples of the carrier braider 150 with 48 spindles 153or individual carriers 155 are provided herein, some embodiments of thecarrier braider 150 may include 6 to 144 spindles 153 or individualcarriers 155 in accordance with the values provided above and/or carrierbraiders 150 that have 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, etc.spindles 153 or individual carriers 155, and the number and positioningof radiopaque filaments can remain as provided in the example braidcarrier mechanism 4080 setup.

FIG. 8L is an x-ray photograph illustrating an example of a plurality ofradiopaque filaments of the distal portion 4000 of FIG. 8J, in which theradiopaque filaments 4011, 4013, 4015, 4017 form a dual double helix orfour sine waves, pairs of which are offset by about 180° and the sinewaves in each pair being offset from each other by about 7.5°. In someembodiments, crossings of the radiopaque filaments 4011, 4013, 4015,4017 of the distal portion 4000 can be used as a rough measurementguide. For example, in FIG. 8L, the spacing between helicalintersections points is about 2 mm, which can help serve as anangiographic measurement ruler. For example, the distal portion 4000 canhelp measure the length of blood clots, the neck of an aneurysm, thelength of a stenosis, etc.

FIG. 8M is a schematic side elevational view of still another exampleembodiment of a distal portion 4100 of a vascular treatment deviceillustrating an example pattern of radiopaque filaments, for exampleunder x-ray. The distal portion 4100 may be the distal portion 100 ofthe device 10, 20, 30, or 40. The distal portion 4100 includes, in anexpanded state, a proximal neck 70 and a cylindrical wide-mouthedtextile structure 75 including shape-memory filaments and radiopaquefilaments. The textile structure 75 expands radially outwardly fromproximal to distal, and then stays at the larger diameter until thedistal end. The distal portion 4100 includes, in an expanded state, twotrios of radiopaque filaments 4111, 4113, 4115 and 4117, 4119, 4121 thatare interlaced in the form a paired triple sine wave like a “reinforceddouble helix” at least under x-ray. The pattern of radiopacity can allowan operator of a device comprising the distal portion 4100 to visualizeand identify the distal portion 4100 at least under x-ray. In someembodiments, the reinforced double helix includes troughs and peaks, forexample at the sides of the distal portion 4100 that the reinforceddouble helix at least partially creates. In FIG. 8M, the intersectionpoints 4125, 4135, 4145 along the reinforced double helix aresubstantially uniformly spaced by distances 4130, 4140, 4150, which canallow the distal portion 4100 to serve as an angiographic measurementruler. For example, the distances 4130, 4140, 4150 can help an operatorto measure the length of blood clots, the neck of an aneurysm, thelength of a stenosis, etc. In some embodiments, a distance 4160 betweenpoints 4155, 4165 at least partially along the proximal neck 70 hasdifferent dimensions than the reinforced double helix in the rest of thelarge diameter part of the distal portion 4100, which may serve as anidentifier of the proximal neck 70 beyond which the distal portion 4100should not be deployed.

FIG. 8N is a schematic diagram illustrating an example setup of a braidcarrier mechanism 4180 for forming the distal portion 4100 of FIG. 8M.In FIG. 8N, the half circles with dark shading indicate individualcarriers 155 including spools 154 including shape memory filaments 156,the half circles with hatched shading indicate individual carriers 155including spools 154 including radiopaque filaments 156, and the halfcircles with no shading indicate spindles without spools 154 orfilaments 156. In the arrangement illustrated in FIG. 8N, spindles 4 o,5 i, 7 o, 8 i, 10 o, 11 i, 13 o, 14 i, 16 o, 17 i, 19 o, 20 i, 22 o, 23i, 25 o, 26 i, 28 o, 29 i, 31 o, 32 i, 34 o, 40 o, 41 i, 43 o, 44 i, 46o, 47 i, 49 o, 50 i, 52 o, 53 i, 55 o, 56 i, 58 o, 59 i, 61 o, 62 i, 64o, 65 i, 67 o, 68 i, 70 o include spools 154 including shape-memorymaterial (e.g., 42 of the 48 filaments 156 comprise shape-memorymaterial), the spindles 1 o, 3 i, 35 i, 37 o, 39 i, 71 i include spools154 including radiopaque material (e.g., 6 of the 48 filaments 156comprise radiopaque material), and the remaining spindles are empty. Thebraid carrier mechanism 4180 setup illustrated in FIG. 8N can generate apattern of radiopacity described with respect to FIG. 8M, for examplepairs of triple sine waves or a reinforced double helix pattern.Although some examples of the carrier braider 150 with 48 spindles 153or individual carriers 155 are provided herein, some embodiments of thecarrier braider 150 may include 6 to 144 spindles 153 or individualcarriers 155 in accordance with the values provided above and/or carrierbraiders 150 that have 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, etc.spindles 153 or individual carriers 155, and the number and positioningof the radiopaque filaments can remain as provided in the example braidcarrier mechanism 4180 setup.

FIG. 8O is a photograph illustrating a plurality of radiopaque filamentsof the distal portion 4100 of FIG. 8M. The distal portion 4100 includesa plurality of shape-memory filaments and a plurality of radiopaquefilaments over a mandrel, in which the radiopaque filaments form areinforced double helix or in which the radiopaque filaments form pairsof sine waves trios, one of which includes the radiopaque filaments4111, 4113, 4115. The trios are offset by about 180° and the sine wavesin each trio are offset from each other by about 7.5°. In someembodiments, crossings of the radiopaque filaments of the distal portion4100 can be used as a rough measurement guide. For example, in FIG. 8O,the spacing between the crossings of the helical intersections points isabout 2 mm, which can help serve as an angiographic measurement ruler.For example, the distal portion 4100 can help measure the length ofblood clots, the neck of an aneurysm, the length of a stenosis, etc.

FIG. 8P is a schematic side elevational view of yet still anotherexample embodiment of a distal portion 4200 of a vascular treatmentdevice, for example of the distal portion 100 of the device 10, 20, 30,or 40. The distal portion 4200 includes, in an expanded state, aproximal neck 70 and a cylindrical wide-mouthed textile structure 75including shape-memory filaments and radiopaque filaments. The textilestructure 75 expands radially outwardly from proximal to distal, andthen stays at the larger diameter until the distal end. The distalportion 4200 includes three radiopaque filaments 4211, 4212, 4213 thatform a three sine waves like a “three phase helix” at least under x-ray.FIG. 8Q is a magnified view of the radiopaque filaments 4211, 4212, 4213of the distal portion 4200 of FIG. 8P, for example under x-ray. FIG. 8Qillustrates the filament 4211 as a solid line, the filament 4212 as adashed line, and the filament 4213 as a dash-dot-dot line for easierdifferentiation between the filaments 4211, 4212, 4213. In someembodiments, the first radiopaque filament 4211 forms a sine wave havinga phase A, the second radiopaque filament 4212 forms a sine wave havinga phase B, and the third radiopaque filament 4213 forms a sine wavehaving a phase C. In some embodiments, the three phase helix includestroughs and peaks, for example at the sides of the distal portion 4200that the three sine waves at least partially create.

The distance between two similarly situated points on a sine wave (e.g.,a first intersection of a sine wave and the central longitudinal axis ofthe distal portion and the next intersection of the sine wave with thecentral longitudinal axis after forming a peak and a trough, thedistance between a first peak of a sine wave and the next peak of thesine wave, the distance between a first trough of the sine wave and thenext trough of the sine wave, etc.) is called the pitch or period orwavelength or cycle of the sine wave. Embodiments comprising a threephase sine wave include three pitches: the sine wave formed by theradiopaque filament 4211 has a pitch 4221, the sine wave formed by theradiopaque filament 4212 has a pitch 4222, and the sine wave formed bythe radiopaque filament 4213 has a pitch 4223. FIG. 8P shows the pitches4221, 4222, 4223 as the distances between the lower peaks of therespective sine waves, and FIG. 8Q shows the pitches 4221, 4222 as thedistances between the upper peaks of the respective sine waves. In theembodiments illustrated in FIGS. 8P and 8Q, the pitches of the sinewaves formed by the radiopaque filaments 4211, 4212, 4213 havesubstantially uniform dimensions (e.g., pitches), except near theproximal neck 70, although the sine waves may have differing dimensions(e.g., pitches).

In some embodiments, the distance between each trough or peak of aradiopaque filament 4211, 4212, 4213 with another trough or peak of anadjacent radiopaque filament of the three phase helix is called a phaseshift. In FIG. 8P, phase A is offset from phase B by about 7.5° (shownby the distance 4231), phase B is offset from phase C by about 7.5°(shown by the distance 4232), and phase A is offset from phase C byabout 15° (shown by the distance 4233). FIG. 8P shows the phase shits4231, 4232, 4233 as the distances between the upper peaks of therespective sine waves, and FIG. 8Q shows the phase shifts 4231, 4232,4233 as the distances between the centers following upper peaks of therespective sine waves. The pattern of radiopacity can allow an operatorof a device comprising the distal portion 4200 to visualize and identifythe distal portion 4200 at least under x-ray. In FIGS. 8P and 8Q, theintersection points along the three phase helix are substantiallyuniformly spaced by distances 4241 or multiples thereof (e.g., thedistance 4243 is the distance between three intersection points, thedistance 4242 in FIG. 8S is the distance between two intersectionpoints, etc.), which can allow the distal portion 4200 to serve as anangiographic measurement ruler. For example, the distances 4241, 4242,4243 can help an operator to measure the length of blood clots, the neckof an aneurysm, the length of a stenosis, etc. In some embodiments,distances between intersection points at least partially along the threephase helix near the proximal neck 70 have different dimensions than thethree phase helix in the rest of the large diameter portion of thedistal portion 4200, which may serve as an identifier of the proximalneck 70 beyond which the distal portion 4200 should not be deployed.

FIG. 8R is a schematic diagram illustrating an example setup of a braidcarrier mechanism 4280 for the distal portion 4200 of FIG. 8P. In FIG.8R, the half circles with dark shading indicate individual carriers 155including spools 154 including shape memory filaments 156, the halfcircles with hatched shading indicate individual carriers 155 includingspools 154 including radiopaque filaments 156, and the half circles withno shading indicate spindles without spools 154 or filaments 156. In thearrangement illustrated in FIG. 8R, spindles 2 i, 4 o, 5 i, 7 o, 8 i, 10o, 11 i, 13 o, 14 i, 16 o, 17 i, 19 o, 20 i, 22 o, 23 i, 26 i, 28 o, 29i, 31 o, 32 i, 34 o, 35 i, 37 o, 40 o, 41 i, 43 o, 44 i, 46 o, 47 i, 50i, 52 o, 53 i, 55 o, 56 i, 58 o, 59 i, 61 o, 62 i, 64 o, 65 i, 67 o, 68i, 70 o, 71 i include spools 154 including shape-memory material (e.g.,45 of the 48 filaments 156 comprise shape-memory material), the spindles1 o, 25 o, 490 include spools 154 including radiopaque material (e.g., 3of the 48 filaments 156 comprise radiopaque material), and the remainingspindles are empty. The braid carrier mechanism 4280 setup illustratedin FIG. 8Q can generate a pattern of radiopacity described with respectto FIG. 8P, for example a three phase-shifted sine waves or a threephase helix pattern. Although some examples of the carrier braider 150with 48 spindles 153 or individual carriers 155 are provided herein,some embodiments of the carrier braider 150 may include 6 to 144spindles 153 or individual carriers 155 in accordance with the valuesprovided above and/or carrier braiders 150 that have 6, 12, 24, 36, 48,60, 72, 84, 96, 120, 144, etc. spindles 153 or individual carriers 155,and the number and positioning of the radiopaque filaments can remain asprovided in the example braid carrier mechanism 4280 setup.

FIG. 8S is an x-ray photograph illustrating an example of a plurality ofradiopaque filaments 4211, 4212, 4213 of the distal portion 4200 of FIG.8P, in which the radiopaque filaments 4211, 4212, 4213 form a threephase helix, or in which the radiopaque filaments form three sine wavesoffset by about 120°. In some embodiments, crossings or intersectionpoints of the radiopaque filaments 4211, 4212, 4213 of the distalportion 4200 can be used as a rough measurement guide. For example, inFIG. 8S, the distance 4242 between the three intersections points isabout 1 mm, which can allow the distal portion 4200 to serve as anangiographic measurement ruler. For example, the distance 4242 can anoperator to measure the length of blood clots, the neck of an aneurysm,the length of a stenosis, etc. Use of other distances are also possible(e.g., a distance 4241 between two intersection points (e.g., as shownin FIG. 8P), a distance 4243 between four intersection points (e.g., asshown in FIG. 8P), distances between similar portions of one or moresine waves (e.g., peaks, troughs, etc.), etc.).

FIG. 8T-1 is a schematic side elevational view of still yet anotherexample embodiment of a distal portion 4300 of a vascular treatmentdevice illustrating an example pattern of radiopaque filaments, forexample under x-ray. The distal portion 4300 may be the distal portion100 of the device 10, 20, 30, or 40. The distal portion 4300 includes,in an expanded state, a proximal neck 70 and a cylindrical wide-mouthedtextile structure including shape-memory filaments and radiopaquefilaments. The textile structure 75 expands radially outwardly fromproximal to distal, and then stays at the larger diameter until thedistal end.

FIG. 8T-2 is a schematic side elevational view of another exampleembodiment of the distal portion 4370 of a vascular treatment deviceillustrating an example pattern of radiopaque filaments 4311, 4312,4313, for example under x-ray. The distal portion 4370 may be the distalportion 100 of the device 10, 20, 30, or 40. In FIG. 8T-2, the distalportion 4370 comprises a plurality of woven bulbs, woven necks, aproximal neck 70, and a distal neck tip 65, for example similar to thedistal portion 1100 of FIG. 2B.

The distal portions 4300, 4370 include, in an expanded state, radiopaquefilaments 4311, 4312, 4313 that are interlaced in the form a three phasehelix at least under x-ray. One or more of the filaments 4311, 4312,4313 may be reinforced (e.g., the filament 4311) with a secondradiopaque filament and the distal portions 4300, 4370 may includeadditional radiopaque filaments that are non-reinforced (e.g., thefilaments 4312, 4313), for example as described herein with respect toFIG. 8T-3. The pattern of radiopacity can allow an operator of a devicecomprising the distal portion 4300, 4370 to visualize identify thedistal portion 4300, 4370 at least under x-ray. In some embodiments, thethree phase helix includes troughs and peaks, for example at the sidesof the distal portion 4300, 4370 that the paired three phase helix atleast partially create. In FIGS. 8T-1 and 8T-2, the intersection pointsalong the triple helix are substantially uniformly spaced, which canallow the distal portion 4300, 4370 to serve as an angiographicmeasurement ruler. For example, the distances between intersections canhelp an operator to measure the length of blood clots, the neck of ananeurysm, the length of a stenosis, etc. In some embodiments, a distanceat least partially along the proximal neck 70, along the distal neck 65,and/or along the bulbs has different dimensions than paired triple helixin the rest of the distal portion 4300, which may serve as an identifierof the proximal neck 70, the distal neck 65, and/or the bulbs, forexample beyond which the distal portion 4300, 4370 should not bedeployed.

FIG. 8T-3 is a schematic diagram illustrating an example setup of abraid carrier mechanism 4380 for the distal portions 4300, 4370 of FIGS.8T-1 and 8T-2. In FIG. 8T-3, the half circles with dark shading indicateindividual carriers 155 including spools 154 including shape memoryfilaments 156, the half circles with hatched shading indicate individualcarriers 155 including spools 154 including radiopaque filaments 156,and the half circles with no shading indicate spindles without spools154 or filaments 156. In the arrangement illustrated in FIG. 8T-3,spindles 4 o, 5 i, 7 o, 8 i, 10 o, 11 i, 14 i, 16 o, 17 i, 19 o, 20 i,22 o, 23 i, 28 o, 29 i, 31 o, 32 i, 34 o, 35 i, 40 o, 41 i, 43 o, 44 i,46 o, 47 i, 52 o, 53 i, 55 o, 56 i, 58 o, 59 i, 62 i, 64 o, 65 i, 67 o,68 i, 70 o, 71 i include spools 154 including shape-memory material(e.g., 39 of the 48 filaments 156 comprise shape-memory material), thespindles 1 o, 2 i, 13 o, 25 o, 26, 37 o, 49 o, 50 i 61 o include spools154 including radiopaque material (e.g., 9 of the 48 filaments 156comprise radiopaque material), and the remaining spindles are empty. Thebraid carrier mechanism 4380 setup illustrated in FIG. 8T-3 can generatea pattern of radiopacity described with respect to FIGS. 8T-1 and 8T-2,for example a reinforced three phase helix (including a sine wave formedby each radiopaque filament pairs 1 o/2 i, 25 o/26 i, 49 o/50 i) and anon-reinforced three phase helix (including a sine wave formed by eachsingle radiopaque filament 13 o, 37 o, 61 o) or a reinforced three phasehelix. Although some examples of the carrier braider 150 with 48spindles 153 or individual carriers 155 are provided herein, someembodiments of the carrier braider 150 may include 6 to 144 spindles 153or individual carriers 155 in accordance with the values provided aboveand/or carrier braiders 150 that have 6, 12, 24, 36, 48, 60, 72, 84, 96,120, 144, etc. spindles 153 or individual carriers 155 and the numberand positioning of the radiopaque filaments can remain as provided inthe example braid carrier mechanism 4380 setup. Different weights arealso possible. For example, a reinforced three phase helix may includethree or more radiopaque filaments per phase. For another example, anon-reinforced three phase helix may include more than one radiopaquefilament per phase, for example as long as the reinforced three phasehelix in that paired three phase helix includes more filaments per wavesuch that the latter is relatively reinforced.

FIG. 8T-4 is an x-ray photograph illustrating an example of a pluralityof radiopaque filaments of the distal portion 4370 of FIG. 8T-2. Thedistal portion 4370 includes a proximal neck 70 and a distal neck 65,and includes a plurality of radiopaque filaments in which the radiopaquefilaments form a reinforced three phase helix. In some embodiments,crossings of the radiopaque filaments 4311, 4312, 4313, 4314, 4315 ofthe distal portion 43700 can serve as an angiographic measurement ruler.For example, the distances between the crossings can help an operator ofa device comprising the distal portion 4370 to measure the length ofblood clots, the neck of an aneurysm, the length of a stenosis, etc.Other features can also be used. For example, in FIG. 8T-4, the width ofa bulb measurable due to the paired triple helix is about 2 mm.

FIG. 8U is a schematic side elevational view of another exampleembodiment of a distal portion 4390 of a vascular treatment deviceillustrating an example pattern of radiopaque filaments, for exampleunder x-ray. The distal portion 4390 may be the distal portion 100 ofthe device 10, 20, 30, or 40. The distal portion 4390 includes, in anexpanded state, a proximal neck 70 and a cylindrical wide-mouthedtextile structure including shape-memory filaments and radiopaquefilaments. The textile structure 75 expands radially outwardly fromproximal to distal, and then stays at the larger diameter until thedistal end.

The distal portion 4390 includes, in an expanded state, radiopaquefilaments 4311, 4312, 4313 that are interlaced in the form a pairedthree phase helix at least under x-ray. The filaments 4311, 4312, 4313may be reinforced with a second radiopaque filament and additional thedistal portions 4390 may include additional radiopaque filaments thatare non-reinforced. The pattern of radiopacity can allow an operator ofa device comprising the distal portion 4390 to visualize identify thedistal portion 4390 at least under x-ray. In some embodiments, thepaired three phase helix includes troughs and peaks, for example at thesides of the distal portion 4390 that the paired three phase helix atleast partially creates. A paired three phase helix includes a pitch foreach reinforced filament (e.g., a pitch 4321 for the sine wave createdby the filaments 4311, a pitch 4322 for the sine wave created by thefilaments 4312, and a pitch 4323 for the sine wave crated by thefilaments 4313) and a pitch for each non-reinforced filament (e.g., apitch 4341 for the sine wave created by the filament 4314, a pitch 4342for the sine wave created by the filament 4315, a pitch 4343 for thesine wave created by the filament 4316). In FIG. 8U, the intersectionpoints along the paired triple helix are substantially uniformly spaced,which can allow the distal portion 4390 to serve as an angiographicmeasurement ruler. For example, the distances between intersections canhelp an operator to measure the length of blood clots, the neck of ananeurysm, the length of a stenosis, etc. In some embodiments, a distanceat least partially along the proximal neck 70, along the distal neck 65,and/or along the bulbs has different dimensions than paired triple helixin the rest of the distal portion 4380, which may serve as an identifierof the proximal neck 70, the distal neck 65, and/or the bulbs, forexample beyond which the distal portion 4390 should not be deployed.

FIG. 8V is a schematic diagram illustrating an example setup of a braidcarrier mechanism 4385 for the distal portion 4390 of FIG. 8U. In FIG.8U, the half circles with dark shading indicate individual carriers 155including spools 154 including shape memory filaments 156, the halfcircles with hatched shading indicate individual carriers 155 includingspools 154 including radiopaque filaments 156, and the half circles withno shading indicate spindles without spools 154 or filaments 156. In thearrangement illustrated in FIG. 8U, spindles 4 o, 5 i, 7 o, 8 i, 10 o,11 i, 14 i, 16 o, 17 i, 19 o, 20 i, 22 o, 23 i, 28 o, 29 i, 31 o, 32 i,34 o, 35 i, 40 o, 41 i, 43 o, 44 i, 46 o, 47 i, 52 o, 53 i, 55 o, 56 i,58 o, 59 i, 62 i, 64 o, 65 i, 67 o, 68 i, 70 o, 71 i include spools 154including shape-memory material (e.g., 39 of the 48 filaments 156comprise shape-memory material), the spindles 1 o, 2 i, 13 o, 25 o, 26,37 o, 49 o, 50 i 61 o include spools 154 including radiopaque material(e.g., 9 of the 48 filaments 156 comprise radiopaque material), and theremaining spindles are empty. The braid carrier mechanism 4385 setupillustrated in FIG. 8V can generate a pattern of radiopacity describedwith respect to FIG. 8U, for example a reinforced three phase helix(including a sine wave formed by each radiopaque filament pairs 1 o/2 i,25 o/26 i, 49 o/50 i) and a non-reinforced three phase helix (includinga sine wave formed by each single radiopaque filament 13 o, 37 o, 61 o)or a reinforced three phase helix. Although some examples of the carrierbraider 150 with 48 spindles 153 or individual carriers 155 are providedherein, some embodiments of the carrier braider 150 may include 6 to 144spindles 153 or individual carriers 155 in accordance with the valuesprovided above and/or carrier braiders 150 that have 6, 12, 24, 36, 48,60, 72, 84, 96, 120, 144, etc. spindles 153 or individual carriers 155and the number and positioning of the radiopaque filaments can remain asprovided in the example braid carrier mechanism 4380 setup. Differentweights are also possible. For example, a reinforced three phase helixmay include three or more radiopaque filaments per phase. For anotherexample, a non-reinforced three phase helix may include more than oneradiopaque filament per phase, for example as long as the reinforcedthree phase helix in that paired three phase helix includes morefilaments per wave such that the latter is relatively reinforced.

FIG. 8W illustrates a paired three phase helix including a reinforcedtriple helix and a non-reinforced triple helix. The reinforced triplehelix includes a first sine wave formed by the two radiopaque filaments4311, a second sine wave formed by the two radiopaque filaments 4312,and a third sine wave formed by the two radiopaque filaments 4313. Thenon-reinforced three phase helix includes a first sine wave formed bythe radiopaque filament 4314, a second sine wave formed by theradiopaque filament 4315, and a third sine wave formed by the radiopaquefilament 4316. In some embodiments, each sine wave within the reinforcedthree phase helix is offset from the adjacent sine wave within thereinforced three phase helix by about 120° and each sine wave within thenon-reinforced three phase helix is offset from the adjacent sine wavewithin the non-reinforced three phase helix by about 120°.

FIG. 8X is a schematic side elevational view of yet another exampleembodiment of the distal portion 4600 of a vascular treatment deviceillustrating an example pattern of radiopaque filaments, for exampleunder x-ray. The distal portion 4600 may be the distal portion 100 ofthe device 10, 20, 30, or 40. The distal portion 4600 includes aplurality of woven spherical bulbs 4617, 4619, a woven neck 4631, aproximal neck 70, and a distal neck 65 along a longitudinal axis 4640.The distal portion 4600 includes relatively low braid angle segments4611, 4615. In some embodiments, the segments 4611, 4615 have braidangles ranging from about 0° to about 90° (e.g., about 17°, about 22°,about 45°, etc.). Lower braid angle segments generally have lower PPIand tend to have relatively high porosity. Lower PPI can result in alarger pore size, which can allow adequate flow into perforating vesselsor small blood vessels adjoining blood clot, an aneurysm, or a vascularmalformation such as an arterio-venous fistula, which can maintain flowin these small but important blood vessels. The distal portion 4600further includes a relatively high braid angle segment 4613. In someembodiments, the segment 4613 has braid angles ranging from about 91° toabout 180° (e.g., about 111°, about 112°, about 151°, etc.). Higherbraid angle segments generally have a higher PPI and tend to haverelatively low porosity. Higher PPI can result in a smaller pore size,which can decrease flow into an aneurysm or a vascular malformation suchas an arterio-venous fistula, which can aid in thrombosis of theaneurysm or vascular malformation.

Referring back to FIG. 8A, at least two variables can be modified toimpact porosity: (1) ability to vary the speed of rotation of thecircular horn gear 152 for an entire rotation of the horn gear 152 inthe horizontal direction 166 relative to the speed of motion of thevertical ring or puller 161 in the vertical direction 164 along themandrel 162; and (2) ability to start or stop movement of the verticalpuller 161, and, once stopped, ability to rearrange the spools 154 withfilaments from one spindle 153 to another (“Start-Stop”). Changes in oneor both of these variables can directly affect, for example, braid angleand porosity. In some embodiments in which the speed of rotation S_(h)in the horizontal direction of the circular horn gear 152 is faster thanthe speed of motion S_(v) in the vertical direction of the puller 161such that the horn gear ratio (S_(h)/S_(v)) is greater than 1.0, a highbraid angle and relative low porosity can be obtained. In someembodiments in which the speed of rotation S_(h) in the horizontaldirection of the circular horn gear 152 is slower than the speed ofmotion S_(y) in the vertical direction of the puller 161 such that thehorn gear ratio (S_(h)/S_(v)) is less than 1.0, a lower braid angle anda relative high porosity can be obtained.

In some embodiments, crossings of the radiopaque filaments of the distalportion 4600 can be used as a guide for deployment of the distal portion4600. For example, the “circumferential asymmetric” radiopaque patternmay serve as a visual guide to understand the deployment of woven bulbsby observation of an asymmetric pattern including low braid angles andthe deployment of necks by observation of a symmetric pattern includinghigh braid angles.

FIG. 8Y is a schematic diagram illustrating an example setup of a braidcarrier mechanism 4680 for the distal portion 4600 of FIG. 8Xillustrating a pattern of a “circumferential asymmetric helix.” In FIG.8Y, the half circles with dark shading indicate individual carriers 155including spools 154 including shape memory filaments 156, the halfcircles with hatched shading indicate individual carriers 155 includingspools 154 including radiopaque filaments 156, and the half circles withno shading indicate spindles without spools 154 or filaments 156. In thearrangement illustrated in FIG. 8Y, spindles 4 o, 5 i, 7 o, 8 i, 10 o,11 i, 13 o, 14 i, 16 o, 17 i, 19 o, 20 i, 22 o, 23 i, 28 o, 29 i, 31 o,32 i, 34 o, 35 i, 40 o, 41 i, 43 o, 44 i, 46 o, 47 i, 52 o, 53 i, 55 o,56 i, 58 o, 59 i, 61 o, 62 i, 64 o, 65 i, 67 o, 68 i, 70 o, 71 i includespools 154 including shape-memory material (e.g., 39 of the 48 filaments156 comprise shape-memory material) spindles 1 o, 2 i, 25 o, 26 i, 49 o,50 i, 31 o, 37 o, 43 o include spools 154 including radiopaque material(e.g., 9 of the 48 filaments 156 comprise radiopaque material), and theremaining spindles are empty. The braid carrier mechanism setup 4680illustrated in FIG. 8Y can generate a pattern of radiopacity describedwith respect to FIG. 8X, for example a reinforced three phase helix anda non-reinforced asymmetric three phase helix to form a “circumferentialasymmetric” radiopacity pattern. Although some examples of the carrierbraider 150 with 48 spindles 153 or individual carriers 155 are providedherein, some embodiments of the carrier braider 150 may include 6 to 144spindles 153 or individual carriers 155 in accordance with the valuesprovided above and/or carrier braiders 150 that have 6, 12, 24, 36, 48,60, 72, 84, 96, 120, 144, etc. spindles 153 or individual carriers 155.

In some embodiments, each sine wave within the reinforced three phasehelix is offset from the adjacent sine wave within the three phase helixby about 120° and each sine wave within the non-reinforced three phasehelix is offset from the adjacent sine wave by about 37.5°. Thereinforced three phase helix is asymmetrically offset from thenon-reinforced three phase helix.

FIGS. 8L, 8S, and 8T-4 each include a scale to provide a rough,non-limiting, sizing of an example of a distal portion 100 and spacingbetween radiopaque filaments. In some embodiments, crossings of theradiopaque filaments of the distal portion 100 can be used as a roughmeasurement guide. For example, in FIG. 8S, every two crossings or thedistance between two helical intersection points is about 1 mm. Foranother example, in FIG. 8L, every one crossing is about 2 mm. In aradially expanded state in a vessel, the distal portion 100 may notachieve full radial expansion (e.g., limited by the sidewalls of thevessel), so the guides are not precise, but can provide approximationfor, e.g., deployment length, clot length, neck of the aneurysm,stenosis length, etc.

If the distance between helical intersection points is substantiallyuniform (e.g., about 5 mm), then the user can determine that unsheathingup to 4 intersection points unsheathes about 20 mm (4×5 mm) of thedistal portion 100. If the distance between helical intersection pointsis variable (e.g., about 5 mm proximate to the distal end of the distalportion 100 and about 10 mm proximate to the proximal end of the distalportion 100, with stepped or intermediate distances therebetween), thenthe user can determine that visualization of wider distances areapproaching unsheathing of the proximal end of the distal portion 100,which can be useful, for example, when treating long clots (e.g., longclots in neuro and/or peripheral vessels, treatment of critical limbischemia, etc.) and/or which can serve as a visual guide for when tostop unsheathing the distal portion 100 during device deployment.

Certain arrangements of radiopaque filaments, for example a double helixor a three phase helix, may be easier to see and/or use for lengthapproximation. In some embodiments, a double helix may include betweenabout 1 radiopaque strand and about 12 radiopaque strands concentratedaround part of a circumference of a distal portion 100 (e.g., adjacentto each other, spaced by less than about 5 non-radiopaque filaments,less than about 3 non-radiopaque filaments, less than about 2non-radiopaque filaments, etc.). In some embodiments, the double helixmay comprise a simple double helix which may include about 2 radiopaquestrands (e.g., one strand for each helix), a dual double helix which mayinclude about 4 radiopaque strands (e.g., two strands for each helix),and/or a reinforced double helix which may include about 6 radiopaquestrands (e.g., three strands for reinforcing each helix), about 8radiopaque strands (e.g., four strands for reinforcing each helix),about 60 radiopaque strands (e.g., 30 strands for reinforcing eachhelix), etc. A double helix may be created, for example, by placing atleast two spools 154 including radiopaque filaments 156 adjacent to eachother around a circumference of the distal portion 100. Circumferentialadjacentness may by produced, for example, by placing spools 154including radiopaque filaments 156 on adjacent spindles 153 or spindles153 without a non-radiopaque filament therebetween on the yarn wheel152.

In some embodiments, the three phase helix may comprise a simple threephase helix, which may include about 3 radiopaque strands, a reinforcedthree phase helix, which may include about 4 radiopaque strands (e.g.,two strands for reinforcing one of the phases and one strand for each ofthe other two phases), and/or a circumferential helix with a reinforcedthree phase helix, which may include between about 9 radiopaque strands(e.g., six strands for reinforcing the three phase helix and threestrands for the non-reinforced three phase helix), about 12 radiopaquestrands (e.g., nine strands for reinforcing the three phase helix, andthree strands for the non-reinforced three phase helix), about 15radiopaque strands (e.g., twelve strands for reinforcing the three phasehelix, and three strands for the non-reinforced three phase helix),about 60 radiopaque strands (e.g., 54 strands for reinforcing each helixreinforcing the three phase helix, and six strands for thenon-reinforced three phase helix), etc. In some embodiments, referringto FIG. 8U, a ratio of the number of radiopaque filaments in thereinforced three phase helix to the number of radiopaque filaments inthe non-reinforced three phase helix may include ratios of about 2:1,about 3:1, about 4:1, about 9:1, etc.

FIG. 8Z is a schematic magnified side elevational view of still anotherexample embodiment of a distal portion 4500 of a vascular treatmentdevice illustrating an example pattern of radiopaque filaments 4520. Thedistal portion 4500 may be the distal portion 100 of the device 10, 20,30, or 40. The distal portion 4500 includes, in an expanded state, atextile structure including shape-memory filaments (not shown) andradiopaque filaments 4520. The distal portion 4500 includes a pluralityof zones 4510 along the longitudinal axis 4540. The plurality of zones4510 includes a first zone 4511, a second zone 4513, and a third zone4515. The first zone 4511 includes different braid angles than thesecond zone 4513. The second zone 4513 includes different braid anglesthan the third zone 4515. In the embodiment illustrated in FIG. 8Z, thefirst zone 4511 includes the same braid angles than the third zone 4515,although the first zone 4511 may includes different braid angles thanthe third zone 4515. In some embodiments, the radiopaque filaments 4520form a “circumferential asymmetric helix” 4510.

Referring again to FIG. 8A, the braiding parameters may be varied toproduce the desired properties of the textile structure 158, including,for example braid angle, PPI, pore size, porosity, etc. There are atleast two variables that can be modified to directly affect the braidangle: (1) speed of rotation of the horn gear 152 for an entire rotationof the horn gear 152 in the horizontal direction 166; and (2) speed ofmotion of the puller or ring 161 in the vertical direction 164 along themandrel 162. Changes in one or both of these variables can directlyaffect, for example, braid angle. In some embodiments in which the speedof rotation in the horizontal direction (S_(h)) of the circular horngear 152 is faster than the speed of motion in the vertical direction(S_(w)) of the puller 161 such that the horn gear ratio (S_(h)/S_(v)) isgreater than 1.0, a high braid angle can obtained. In some embodimentsin which the speed of rotation in the horizontal direction of thecircular horn gear 152 is slower than the speed of motion in thevertical direction of the puller 161 such that the horn gear ratio(S_(h)/S_(v)) is less than 1.0, a lower braid angle can be obtained.Referring again to FIG. 8Z, the first zone 4511 of the distal portion4500 has a relatively low braid angle, implying that the horn gear ratiois less than 1.0, the second zone 4513 of the distal portion 4500 has arelatively high braid angle, implying that the horn gear ratio isgreater than 1.0, and the third zone 4515 of the distal portion 4500 hasa relatively low braid angle, implying that the horn gear ratio is lessthan 1.0.

Although shown with respect to a single radiopaque filament 4520 of aradiopaque pattern that may be formed, for example, by the braid carriermechanism 2870 shown in FIG. 8G, variation of the horn gear ratio can beused to vary braid angles of a plurality of shape-memory and radiopaquefilaments in any braid carrier mechanism setup (e.g., the braid carriermechanisms setups shown in FIGS. 8B, 8I, 8K, 8N, 8R, 8T-3, 8V, etc.). Inbraid carrier mechanism setups including radiopaque filaments, the braidangle may be varied along the longitudinal length of the device beingbraided.

FIG. 9A is a schematic magnified side elevational view of a portion ofanother example embodiment of a distal portion 8300 of a vasculartreatment device illustrating an example pattern of one or morefilaments 8320. The distal portion 8300 may be the distal portion 100 ofthe device 10, 20, 30, or 40. The distal portion 8300 includes, in anexpanded state, a textile structure including shape-memory and/orradiopaque filaments and a plurality of zones 8310. The filament(s) 8320may be part of a woven textile structure, for example as describedherein. In some embodiments, at least one of the plurality of zones 8310has a different porosity and/or pore size than at least one of the otherof the plurality of zones 8310. Referring back to FIG. 8A, at least twovariables can be modified to directly affect braiding parameters such asporosity or pore size: (1) ability to start or stop movement of thevertical puller 161, and, once stopped, ability to rearrange the spools154 from one spindle 153 to another spindle 153 (“Start-Stop”); and (2)ability to vary speed of rotation of portions of the circular horn gear152. In some embodiments, movement of the vertical puller 161 istemporarily stopped, and the spools 154 including filaments 156 arerearranged from one spindle 153 to another spindle 153 on the braidcarrier mechanism 152 to create a different pattern (e.g., fromsymmetric as shown in FIG. 8V to asymmetric as shown in FIG. 8Y).Adjusting the arrangement of the braid carrier mechanism can vary thepore size in the horizontal plane on either side of the braid axis. Insome other embodiments, the speed of rotation of the circular horn gear152 for a portion of rotation of the yarn wheel 152 (e.g., 180°, or forthe western hemisphere of the yarn wheel 152) is different compared tothe remaining portion of rotation of the yarn wheel 152 (e.g., 180°, orfor the eastern hemisphere of the yarn wheel 152), which can vary poresize and/or porosity in the vertical plane on either side of thelongitudinal axis.

In FIG. 9A, the distal portion 8300 includes a first zone 8311, a secondzone 8312, and a third zone 8315. The second zone 8313 has a higherporosity and/or larger pore size than the first zone 8311 and the thirdzone 8315. In some embodiments, the porosity and/or pore size of thesecond zone may be varied by adjusting at least one of Start-Stop androtation of a portion of the yarn wheel 152 during the braiding process.In some embodiments, the filaments 8320 form a helix including troughsand peaks, for example at the sides the distal portion 8300 that thehelix at least partially creates. In FIG. 9C, the first zone 8311 andthe third zone 8315 have a relatively high PPI and are less porous thanthe second zone 8313. Higher PPI can result in a smaller pore size,which can decrease flow into an aneurysm or a vascular malformation suchas an arterio-venous fistula, which can aid in thrombosis of theaneurysm or vascular malformation. The second zone 8313 has a relativelylow PPI and is more porous than the first zone 8311 and the third zone8315. Lower PPI can result in a larger pore size, which can allowadequate flow into perforating vessels or small blood vessels adjoiningblood clot, an aneurysm, or a vascular malformation such as anarterio-venous fistula, which can maintain flow in these small butimportant blood vessels.

FIG. 9B is a schematic side elevational view of an example embodiment offorming the distal portion 8300 of FIG. 9A. FIG. 9B shows a braidingdevice or carrier braider 150 braiding a pattern in the distal portion8300 including variable pore size. For example as described with respectto FIG. 8A, the braiding device 150 includes a yarn wheel or braidcarrier mechanism or circular horn gear 152 and a plurality of spindles153 and individual carriers 155. A spindle 153 is a stick on thecircular horn gear 152. A spool 154 is a hollow device that fits onto aspindle 153 and includes filaments 156 wound around it. An individualcarrier 155 includes a spindle 153 and a spool 154 on the spindle 153.The terms spindle, spool, and individual carrier may be usedinterchangeably depending on context. The individual carriers 155include spools 154 including filaments 156 that are woven together toform the textile structure of the distal portion 8300. Each spindle pairincludes an outer spindle 5717 and an inner spindle 5715. The filaments156 each extend from an individual carrier 155 to a ring or verticalpuller 161 over a mandrel along the central longitudinal axis 4840, andare braided around the mandrel 160 along the central longitudinal axis4840 by spinning the circular horn gear 152, spinning the spindles 153,and pulling the ring 161 away from the circular horn gear 152 in avertical direction 164. The distal portion 8300 includes filaments thatare left leaning, for example the filaments 8320 that are shown to theleft of the longitudinal axis 4840, and right leaning, for example thefilaments 8320 that are shown to the right of the longitudinal axis4840. In some embodiments, the left leaning filaments correlate with theindividual carriers 4815 in the western hemisphere of the circular braidmechanism or circular horn gear 152 and the right leaning filamentscorrelate with the individual carriers 4825 in the eastern hemisphere ofthe circular braid mechanism or circular horn gear 152. Although someexamples of the carrier braider 150 with 4 spindles 153 or individualcarriers 155 are provided herein, some embodiments of the carrierbraider 150 may include 6 to 144 spindles 153 or individual carriers 155in accordance with the values provided above and/or carrier braiders 150that have 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, etc. spindles 153or individual carriers 155. As the textile structure 8300 is woven atpreform point 160, the textile structure advances in the direction ofthe arrow 164. The circular horn gear 152 spins in the direction of thearrows 166 in a horizontal plane around the longitudinal axis 4840, andthe spindles 153 rotate within the circular horn gear 152 to create thedesired braiding pattern.

FIG. 9C is a schematic diagram illustrating an example setup of a braidcarrier mechanism 2600 for forming the distal portion 8300 of FIG. 9A,illustrating an example pattern for creating variable pore size. In FIG.9C, the half circles with dark shading indicate individual carriers 155including spools 154 including shape memory filaments 154, the halfcircles with hatched shading indicate individual carriers 155 includingspools 154 including radiopaque filaments 156, and the half circles withno shading indicate spindles without o spools 154 or filaments 156.Although some examples of the spindles 153 or individual carriers 155are provided herein, the spindles 153 may include spools 154 includingshape memory material, spools 154 including radiopaque material, beempty, be arranged in symmetric or asymmetric patterns, combinationsthereof, and the like. In the arrangement illustrated in FIG. 9C,spindles 1 o, 2 i, 4 o, 5 i, 7 o, 8 i, 10 o, 11 i, 13 o, 14 i, 16 o, 17i, 19 o, 20 i, 22 o, 23 i, 25 o, 26 i, 28 o, 29 i, 31 o, 32 i, 34 o, 35i, 37 o, 38 i, 40 o, 41 i, 43 o, 44 i, 46 o, 47 i, 49 o, 50 i, 52 o, 53i, 55 o, 56 i, 58 o, 59 i, 61 o, 62 i, 64 o, 65 i, 67 o, 68 i, 70 o, 71i include spools 154 including shape-memory material (e.g., 48 of the 48filaments 156 comprise shape-memory material) and the remaining spindlesare empty. Although some examples of the carrier braider 150 with 48spindles 153 or individual carriers 155 are provided herein, someembodiments of the carrier braider 150 may include 6 to 144 spindles 153or individual carriers 155 in accordance with the values provided aboveand/or carrier braiders 152 that have 6, 12, 24, 36, 48, 60, 72, 84, 96,120, 144, etc. spindles 153 or individual carriers 155.

FIG. 9D is a schematic diagram illustrating another example setup of abraid carrier mechanism 2600 for forming the distal portion 8300 of FIG.9A, illustrating another example pattern for creating variable pore sizeafter rearranging the individual carriers 155 such that all of thespindles 153 with spools 154 including filaments 156 form spindle pairs,which can increase the number of empty spindle pairs and pore size. Inthe arrangement illustrated in FIG. 9D, the spindles 1 o, 1 i, 4 o, 4 i,7 o, 7 i, 10 o, 10 i, 13 o, 13 i, 16 o, 6 i, 19 o, 19 i, 22 o, 22 i, 25o, 25 i, 28 o, 28 i, 31 o, 31 i, 34 o, 34 i, 37 o, 37 i, 40 o, 40 i, 43o, 43 i, 46 o, 46 i, 49 o, 49 i, 52 o, 52 i, 55 o, 55 i, 58 o, 58 i, 61o, 61 i, 64 o, 64 i, 67 o, 67 i, 70 o, 70 i include spools 154 includingshape-memory material (e.g., 48 of the 48 filaments 156 compriseshape-memory material) and the remaining spindles are empty. Compared tothe arrangement illustrated in FIG. 9E, the spool 154 on spindle 2 i wasmoved to the spindle 1 i, the spool 154 on spindle 5 i was moved to thespindle 4 i, the spool 154 on spindle 8 i was moved to the spindle 71,the spool 154 on spindle 11 i was moved to the spindle 10 i, the spool154 on spindle 14 i was moved to the spindle 13 i, the spool 154 onspindle 17 i was moved to the spindle 16 i, the spool 154 on spindle 20i was moved to the spindle 19 i, the spool 154 on spindle 23 i was movedto the spindle 22 i, the spool 154 on spindle 26 i was moved to thespindle 25 i, the spool 154 on spindle 29 i was moved to the spindle 28i, the spool 154 on spindle 32 i was moved to the spindle 31 i, thespool 154 on spindle 35 i was moved to the spindle 34 i, the spool 154on spindle 38 i was moved to the spindle 37 i, the spool 154 on spindle41 i was moved to the spindle 40 i, the spool 154 on spindle 44 i wasmoved to the spindle 43 i, the spool 154 on spindle 47 i was moved tothe spindle 46 i, the spool 154 on spindle 50 i was moved to the spindle49 i, the spool 154 on spindle 53 i was moved to the spindle 52 i, thespool 154 on spindle 56 i was moved to the spindle 55 i, the spool 154on spindle 59 i was moved to the spindle 58 i, the spool 154 on spindle62 i was moved to the spindle 61 i, the spool 154 on spindle 65 i wasmoved to the spindle 64 i, the spool 154 on spindle 68 i was moved tothe spindle 67 i, and the spool 154 on spindle 71 i was moved to thespindle 70 i. Although some examples of the carrier braider 150 with 48spindles 153 or individual carriers 154 are provided herein, someembodiments of the carrier braider 150 may include 6 to 144 spindles 153or individual carriers 155 in accordance with the values provided aboveand/or carrier braiders that have 6, 12, 24, 36, 48, 60, 72, 84, 96,120, 144, etc. spindles 153 or individual carriers 155 and the numberand positioning of the spools 154 including filaments 156 can remain asprovided in the example braid carrier mechanism 2600 setup of FIG. 9D.

In some embodiments, for example the arrangement illustrated in FIG. 9C,can result in a braiding pattern of the distal portion 8300, as noted inFIG. 9B, having a relatively high PPI and relatively low porosity, forexample the distal segment 8311 of the distal portion 8300. If the“Start-Stop” capability is activated after the braiding of the distalsegment 8311 of the distal portion 8300, and once the vertical puller orring 161 is stopped to be able to rearrange the spools 154 includingfilaments 156 between spindles 153 in the arrangement illustrated inFIG. 9D, further braiding can result in a braiding pattern having arelatively low PPI and relatively high porosity, for example the middlesegment 8313 of the distal portion 8300. If the “Start-Stop” capabilityis again activated after the braiding of the middle segment 8313 of thedistal portion 8300, and once the vertical puller or ring 161 is stoppedto be able to rearrange the spools 154 including filaments 156 betweenspindles 153 in the arrangement illustrated in FIG. 9C, further braidingcan result in a braiding pattern having a relatively high PPI andrelatively low porosity, for example the proximal segment 8315 of thedistal portion 8300.

In some embodiments, referring back to FIGS. 9B and 9C, the speed ofrotation of the circular horn gear 152 for 180 degrees rotation of theyarn wheel, for example the speed of rotation S_(h-w) of the westernhemisphere of individual carriers 4815 on the yarn wheel in thehorizontal direction 4817, is different compared to the remaining 180degrees rotation of the yarn wheel, for example the speed of rotationS_(h-e) of the eastern hemisphere of individual carriers 4825 of theyarn wheel in the horizontal direction 4827, which can vary the poresize in the vertical plane on either side of the longitudinal axis 4840.

In the arrangement illustrated in FIGS. 9C and 9D, for example, if thespeed of rotation S_(h-w) in the horizontal direction 4817 of thewestern hemisphere of the circular horn gear 152 is faster than thespeed of motion S_(y) in the vertical direction of the puller 161, thehorn gear ratio (S_(h-w)/S_(y)) is greater than 1.0, and a high braidangle can be obtained. For example, the higher braid angle segments mayhave braid angles ranging from about 91° to about 180° (e.g., about111°, about 112°, about 151°, etc.). Higher braid angle segmentsgenerally have a higher PPI and tend to have relatively low porosity.Higher PPI can result in a smaller pore size, which can decrease flowinto an aneurysm or a vascular malformation such as an arterio-venousfistula, which can aid in thrombosis of the aneurysm or vascularmalformation.

In the arrangement illustrated in FIGS. 9C and 9D, for example, if thespeed of rotation S_(h-e) in the horizontal direction 4827 of theeastern hemisphere of the circular horn gear 152 is slower than thespeed of motion S_(y) in the vertical direction of the puller 161, thehorn gear ratio (S_(h-e)/S_(y)) is less than 1.0, and a lower braidangle can be obtained. For example, the lower braid angle segments mayhave braid angles ranging from about 0° to about 90° (e.g., about 17°,about 22°, about 45°, etc.). Lower braid angle segments generally havelower PPI and tend to have relatively high porosity. Lower PPI canresult in a larger pore size, which can allow flow into perforatingvessels or small blood vessels adjoining blood clot, an aneurysm, or avascular malformation such as an arterio-venous fistula, which canmaintain flow in these small but important blood vessels.

FIG. 9E is a schematic diagram illustrating an example embodiment of amandrel for forming a distal portion of a vascular treatment device, forexample the distal portion 11000 of FIG. 7A and/or the distal portion11100 of FIG. 7B. FIG. 9F is a schematic diagram illustrating anotherexample embodiment of a mandrel for forming a distal portion of avascular treatment device, for example the distal portion 11000 of FIG.7A and/or the distal portion 11100 of FIG. 7B. In the embodimentsillustrated in FIGS. 9E and 9F, the bulbous mandrel can be customizedfor any Y-shaped configuration of the distal portion 100 of a vasculartreatment device.

In FIG. 9E, the bulbous mandrel includes a spherical bulb or centralanchor bulb 11205 and a plurality of retainer cavities includingsprockets. In some embodiments, the retainer cavity and sprockets areinterspersed on substantially the entire outer circumference of thecentral anchor bulb 11205, and have the ability to rotate between about0° and about 180°. Depending on the distal portion 100 to bemanufactured, a first mandrel extension 11210 is coupled to a firstsprocket 11212, a second mandrel extension 11220 is coupled to a secondsprocket 11222, and a third mandrel extension 11230 is coupled to athird sprocket 11232. The remaining sprockets can then be removed. InFIG. 9F, the bulbous mandrel includes a spherical bulb or central anchorbulb 11205 and a plurality of retainer cavities. Depending on the distalportion 100 to be manufactured, a first mandrel extension 11210 iscoupled to a first sprocket 11262, a second mandrel extension 11220 iscoupled to a second sprocket 11242, and a third mandrel extension 11230is coupled to a third sprocket 11252.

Although FIGS. 9E and 9F are shown and described with respect to threemandrel extensions 11210, 11220, 11230, more or fewer mandrel extensionsare also possible. The first mandrel extension 11210 comprises agenerally spherical bulb and a generally cylindrical neck on each sideof the generally spherical bulb, which can allow a neck formed over thefirst mandrel extension 11210 to include a generally spherical bulb anda generally cylindrical neck on each side of the generally sphericalbulb. The second mandrel extension 11220 and the third mandrel extension11230 are each generally cylindrical, which can allow a neck formed overthe second mandrel extension 11220 and the third mandrel extension 11230to be generally cylindrical. Mandrel extensions with any size and shapecan be coupled to the central anchor bulb 11205 depending on the desiredsize and shape of the neck to be formed thereover. In some embodiments,mandrel extensions can be selected to form a distal portion 100customized for a pathology such as a location of an aneurysm, and evensized for a particular patient.

Referring again to FIG. 7A, the lengths L₁, L₂, L₃, and diameters D₁,D₂, D₃), the diameter of the central anchor bulb D₀, and the angulationof the mandrel extensions 11210, 11220, 11230 from the central anchorbulb 11205 can be customized to vasculature, a pathology such aslocation of the aneurysm at a vessel bifurcation, and/or aneurysmdimensions and blood vessel diameters and angulations in a patient innon-emergent situations. Referring again to FIG. 9B, a bulbous mandrelcan be mounted on a carrier braider or braiding device for primarybraiding over the customized bulbous mandrel. In some embodiments, thecustomized bulbous mandrel may include metals or alloys (e.g.,comprising stainless steel or alloy of nickel and titanium). Suitablematerials may include, for example, platinum, titanium, nickel,chromium, cobalt, tantalum, tungsten, iron, manganese, molybdenum, andalloys thereof including nickel titanium (e.g., nitinol), nickeltitanium niobium, chromium cobalt, copper aluminum nickel, ironmanganese silicon, silver cadmium, gold cadmium, copper tin, copperzinc, copper zinc silicon, copper zinc aluminum, copper zinc tin, ironplatinum, manganese copper, platinum alloys, cobalt nickel aluminum,cobalt nickel gallium, nickel iron gallium, titanium palladium, nickelmanganese gallium, stainless steel, shape memory alloys, etc.

Referring again to FIG. 7A, a textile structure formed over the centralanchor bulb 11205 can form the distal generally spherical bulb 11012, atextile structure formed over the mandrel extension 11210 can form theproximal segment including the bulb 11012 and the necks 11016, 11017, atextile structure formed over the mandrel extension 11220 can form thelateral distal neck 11019, and a textile structure formed over themandrel extension 11230 can form the distal neck 11018. Referring againto FIG. 7B, a textile structure formed over the central anchor bulb11205 can form the proximal generally spherical bulb 11105, a textilestructure formed over the mandrel extension 11210 can form the distalsegment including the bulb 11110 and the necks 11115, 11130, a textilestructure formed over the mandrel extension 11220 can form the lateralproximal neck 11120, and a textile structure formed over the mandrelextension 11230 can form the proximal medial neck 11125. Porosity of anysection or portion thereof can be varied, for example as describedherein (e.g., varying speed of a horn gear and/or puller, rearrangingbraid carrier mechanism setups).

After a tubular textile structure 158 is formed, the filaments 156 maybe severed (e.g., close to the mandrel 162), and the textile structure158 may be removed from the mandrel 162. FIG. 10A is a photographillustrating an example woven tubular structure 158 after being removedfrom a mandrel 162. The textile structure 158 is then slid onto a secondmandrel having the same or a substantially similar outer diameter as themandrel 162. The textile structure 158 and the second mandrel are heattreated to impart shape memory to at least some of the filaments 156(e.g., at least the filaments 156 comprising shape-memory material).

The temperature at which a material transforms from Martensite toAustenite depends at least partially on heat treatment of that material,which can influence the super-elastic or shape memory properties of ashape memory material. For example, upon a change in temperature of analloy of nickel and titanium, super-elastic or shape memory propertiesmay be achieved.

In some embodiments, the heat treatment of shape memory allow (e.g.,comprising between about 55.8 wt % and about 57 wt % nickel) isperformed in a fluidized sand bath at an annealing temperature betweenabout 500° C. and about 550° C. (e.g., about 520° C.) for between about5 minutes and about 10 minutes (e.g., about 7 minutes) in an atmosphere(e.g., ambient air). Between at least about room temperature and aboutbody temperature, the textile structure 158 maintains the tubular shapeabsent stress-induced martensite. Heat treatment at annealingtemperatures that are relatively high (e.g., between about 550° C. andabout 600° C.) for between about 20 minutes and about 180 minutes canresult in increasing the temperature range at which the textilestructure 158 displays shape memory effect (e.g., greater than aboutbody temperature). Heat treatment at annealing temperatures that arerelatively low (e.g., between about 400° C. and about 450° C.) forbetween about 2 minutes and about 10 minutes can also result inincreasing the temperature range at which the textile structure 158displays shape memory effect (e.g., greater than about bodytemperature). In some embodiments, heat treatment of shape memoryalloys, for example binary alloys of nickel and titanium with lowernickel content (e.g., between about 54.5 wt % and 55.3 wt % nickel) orternary alloys of nickel, titanium, and cobalt, may be performed atannealing temperatures that are relatively low (e.g., between about 400°C. and about 450° C.) for between about 2 minutes and about 10 minutesmay also result in the textile structure 158 that can maintain thetubular shape between at least about room temperature and about bodytemperature absent stress-induced martensite. The heat treatmenttemperature can be adjusted based on the particular shape-memory alloy.For example, a ternary alloy comprising cobalt may exhibit propertiessimilar to a relatively low nickel shape-memory alloy.

In some embodiments, the heat treatment is performed in a fluidized sandbath in inert atmosphere (e.g., nitrogen, a mixture of hydrogen andnitrogen, a mixture of carbon monoxide, hydrogen, and nitrogen, etc.),which can inhibit surface oxidation (e.g., formation of nickel oxides inalloys of nickel and titanium) of the shape memory materials. In someembodiments, after heat treatment, the distal portion is then placed ina water bath (e.g., between about 20° C. and about 25° C.) for betweenabout 15 minutes and 45 minutes (e.g., about 30 minutes). Rapid heatingand/or cooling can help to retain the shape (e.g., to achieve theaustenite finish temperature A_(f)). In some systems, the mandrel 162may be removed and the textile structure 158 may be heat treated on themandrel 162 (e.g., without transfer to a second mandrel). After thisinitial heat treatment, the textile structure 158 may be referred to asa primary heat set or shape set structure.

FIG. 10B is another photograph illustrating an example woven tubularstructure 4700 after being removed from a mandrel 162, or from asecondary mandrel. The stray filaments ends 4710 on the left side showthat the ends 4710 of the filaments may benefit from further processing.For example, at least some of the ends of the filaments may be bentback, welded (e.g., ball welded), polished (e.g., to a dull end),coupled in sleeves, dip coated (e.g., in polymer such as polyurethane),coupled (e.g., adhered, welded, etc.), for example to an arcuate member(e.g., a radiopaque marker band 1720, for example as illustrated in FIG.5D), combinations thereof, and the like. Lack of filament end treatment(e.g., no radiopaque marker band 1720, polymer, etc.) can allow thedistal portion 100 to have a lower profile when collapsed, for examplebecause compression is only limited to the area of the filaments andspacing therebetween. In embodiments including a radiopaque marker band1720, the radiopaque marker band 1720 may include metals or alloysincluding, but not limited to, iridium, platinum, tantalum, gold,palladium, tungsten, tin, silver, titanium, nickel, zirconium, rhenium,bismuth, molybdenum, combinations, thereof, and the like. In some of theembodiments, a radiopaque marker band 1720 can be sandwich welded to thefree end of the textile structure 158 (e.g., which is being fabricatedinto a distal portion 100 including bulbs). A radiopaque marker band1720 may increase visibility of the distal end of the distal portion 100during interventional procedures. In some embodiments, the ends of thefilaments are not further processed. FIG. 10B also includes a UnitedStates quarter ($0.25 or 25¢) to provide a rough, non-limiting, sizingof an example distal portion 100 and its filaments. In some embodiments,laser cutting can inhibit fraying of the filaments (e.g., by reducingmechanical shear forces during the cutting process).

FIG. 10C is a schematic exploded side elevational view of an exampleembodiment of a mandrel 170, for example for heat treatment of distalportion 100 of a vascular treatment device. In some embodiments, themandrel 170 includes a strand 172 and ten spherical bulbs 174: threedistal extra-small spherical bulbs 176 having an outer diameterconfigured to be oversized to extra-small vessel segments such as the M2segments of the middle cerebral artery (e.g., about 1.5 mm to about 2.25mm); the proximally-next three small spherical bulbs 177 having an outerdiameter configured to be oversized to smaller vessel segments such asthe distal M1 segment of the middle cerebral artery (e.g., about 2.25 mmto about 2.75 mm); the proximally-next two medium spherical bulbs 178having an outer diameter configured to be oversized to medium vesselsegments such as the proximal M1 segment of the middle cerebral artery(e.g., about 2.75 mm to about 3.25 mm); and the proximal two largespherical bulbs 179 having an outer diameter configured to be oversizedto large vessel segments such as the distal supra-clinoid segment of theinternal carotid artery (e.g., about 3.25 mm to about 4 mm). In someembodiments, at least some of the bulbs of the mandrel 170 have a sizeof about 1 mm to about 80 mm (e.g., about 2 mm to about 12 mm). Bulbs inrange of about 1 mm to about 6 mm, about 3 mm to about 4.5 mm, about 0.5mm to about 3 mm (e.g., about 3 mm), 0.75 mm to about 3 mm (e.g., about3 mm), about 3.1 mm to about 3.9 mm (e.g., about 3.5 mm), about 4 mm toabout 4.4 mm (e.g., 4 mm), and about 4.5 mm to about 7.5 mm (e.g., about4.5 mm) may be particular beneficial for smaller clots and/or vessels(e.g., in the brain). Bulbs of the mandrel 170, in range of about 4 mmto about 10 mm and about 5 mm to about 40 mm, may be particularbeneficial for larger clots and/or vessels (e.g., in the leg). Althoughsome example diameters are provided herein, some embodiments of themandrel 170 may include diameters of the bulbs 176, 177, 178, 179 inaccordance with the values provided above and/or diameters that arewithin about ±5%, about ±10%, about ±15%, or about ±20% of any suchvalues.

In some embodiments, the spherical bulbs 176 include a cylindrical hole,proximally to distally, 4941, 4942, 4943, the spherical bulbs 177include a cylindrical hole, proximally to distally, 4944, 4945, 4946,the spherical bulbs 178 include a cylindrical hole, proximally todistally, 4947, 4948, and the spherical bulbs 179 include a cylindricalhole, proximally to distally, 4949, 4951. The holes 4940 may, forexample, be drilled through the centers of the spherical bulbs 174. Theouter diameters of the cylindrical holes 4940 may be oversized to theouter diameter of the strand 172 to allow the spherical bulbs 174 to bethreaded in a direction 1722 over the end 1721 of the strand 172. Thebulbs 174 may be threaded one or more at a time. In some embodiments,the diameter or width of the strand 172 of the mandrel 170 for thedistal portions 100 configured to be deployed in smaller blood vesselsis in the range of about 0.15 mm to about 0.75 mm, about 0.35 mm toabout 0.65 mm (e.g., about 0.38 mm), or about 0.4 mm to about 0.45 mm.In some embodiments, the diameter or width of the strand 172 of themandrel 170 for distal portions 100 configured to be deployed in largerblood vessels in the range of about 1 mm to about 40 mm (e.g., about 5mm to about 20 mm). A tapered configuration of the mandrel 170 can allowfor adequate and safe deployment of the distal portion 100 across bloodvessels with multiple and/or varying diameters (e.g., vasculature thatprogressively reduces in size). In some embodiments, the mandrel 170 mayinclude a wide variety of different bulb parameters such as bulbquantity, shape, size, spacing, phase-shifting with regards to thelongitudinal axis or to a chord of the axis, material parameters,different neck parameters (e.g., neck diameter, neck length, etc.),alignment to the longitudinal axis or to a chord of the axis,combinations thereof, and the like.

FIG. 10D is a photograph showing a side elevational view of an exampleembodiment of a mandrel 170. In some embodiments, the mandrel 170 is thethird mandrel used in fabricating a distal portion 100, after themandrel 162 and the second mandrel used for heat treating. In someembodiments, the mandrel 170 is the second mandrel used in fabricating adistal portion 100, after the mandrel 162 if the mandrel 162 is used forheat treating. The mandrel 170 includes a strand 172 and a plurality ofbulbs 174, for example after assembly of the pieces illustrated in FIG.10C. In some embodiments, the strand 172 may comprise a wire (e.g.,comprising stainless steel or alloy of nickel and titanium), a hypotube,etc. In some embodiments, the bulbs 174 may comprise a ball (e.g.,comprising stainless steel or alloy of nickel and titanium). In someembodiments, the strand 172 has an outer diameter of between about 0.001inches (approx. 0.025 mm) to about 0.0018 inches (approx. 0.045 mm). Thebulbs 174 may comprise solid or hollow structures with a boretherethrough to allow the bulbs 174 to be positioned along the strand172. The bulbs 174 may be coupled to the strand by adhesion (e.g.,epoxy), welding, soldering, combinations thereof, and the like. In someembodiments, the bulbs 174 have an outer diameter that is slightlysmaller (e.g., about a wall thickness smaller or 1 to 2 strandthicknesses smaller) than a desired outer diameter of a bulb of thedistal portion. The bulbs 174 illustrated in FIG. 10D include threegenerally spherical extra-small bulbs 176, three generally sphericalsmall bulbs 177, two generally spherical medium bulbs 178, and twogenerally spherical large bulbs 179, which can help form the distalportion 1100 described above. Other selection and arrangement of bulbs174 is also possible, for example to form other distal portionsdescribed herein or other types of distal portions. In some embodiments,for example to vary the diameter of the necks, the mandrel 170 includeshypotubes between the bulbs 174 having outer diameters corresponding tothe desired inner diameter of the neck at that position. The selectionand arrangement of the bulbs 174 along the strand 172 and optional neckhypotubes allows the formation of a distal portion 100 having bulbs ofnearly any quantity, shape, size, spacing, etc.

FIG. 10E is a schematic diagram illustrating an example embodiment of awoven tubular structure 158 around a mandrel 170. FIG. 10E illustratesthe textile structure 158 being tightened around the mandrel 170 usingwire 180 (e.g., comprising stainless steel) between the two proximallarge bulbs 179. The textile structure 158 can also be tightened aroundthe mandrel 170 using wire 180 or other means between other bulbs 174.

FIG. 10F is a photograph illustrating an example embodiment a woventubular structure 158 around a mandrel 170. FIG. 10F illustrates thetextile structure 158 being tightened around the mandrel 170 using wire180 (e.g., comprising stainless steel or alloy of nickel and titanium)between the left bulb 178 and the right bulb 177, between the right bulb177 and the middle bulb 177, and between the middle bulb 177 and theleft bulb 177. The frayed ends 4710 of the distal tip of the textilestructure 158 are near the distal end of the strand 172. Although themandrel 170 illustrated in FIGS. 10C-10F can be used to form the distalportion 1100 of FIG. 2B, the mandrel 170 can also be used to form otherdistal portions 100, for example not including medium or large bulbs(e.g., a distal portion including three bulbs 178, 179 as illustrated inFIG. 10G, or any desired shape). The wire 180 is wrapped around thetextile structure 158 between the bulbs 174, and the textile structure158 tightens around the bulbs 174. In some embodiments, the wire 180 iswrapped tightly the entire spacing between the bulbs 174 (e.g., to formdiscrete necks and bulbs). In some embodiments, the wire 180 is wrappedmainly at an intermediate point between the bulbs 174 to create a moreundulating pattern without discrete bulbs and necks. Discrete necks andbulbs, or pronounced undulation, may be more effective at treating hardclots than gentle undulations.

FIG. 10G is a schematic side elevational view of another exampleembodiment of a woven tubular structure 158 around a mandrel 170. FIG.10G illustrates the textile structure 158 being tightened around themandrel 170 using wire 180 between the two large spherical bulbs 179near the proximal end of the woven tubular structure 158 and using wire182 between the medium spherical bulb 178 and the distal large sphericalbulb 179. In some embodiments, the wire 185 is wrapped tightly aroundthe textile structure 158 including the strand 172 to form discretevalleys in the region of the wires 180 and 182, and to form discretehills in the region of the bulbs 178 and 179.

FIG. 10H is a schematic side elevational view of another exampleembodiment of a distal portion 5100 of a vascular treatment deviceillustrating a high transition angle θ_(t). The distal portion 5100includes, in an expanded state, a plurality of woven bulbs 5110 and aneck between the bulbs 5105, 5107. The distal portion 5100 may beformed, for example, by tightly wrapping wire, bangles, etc. around thetextile structure 158 during a second heat treatment to form distinctbulbs 5105, 5107. FIG. 10I is a schematic side elevational view ofanother example embodiment of a distal portion 5200 of a vasculartreatment device illustrating a low transition angle θ_(t). The distalportion 5200 includes, in an expanded state, a plurality of woven bulbs5210 and a depression between the bulbs 5205, 5207. The distal portion5200 may be formed, for example, by tightly wrapping wire, bangles, etc.around the center of a neck of the textile structure 158 during a secondheat treatment to form less distinct bulbs 5205, 5207. The distalportions 5100, 5200 may be the distal portion 100 of the device 10, 20,30, or 40. A hill-to-valley transition angle θ_(t) is indicative of theamount of bulging of the bulbs relative to the necks, and is defined asthe angle formed between the slope of the hill towards the valley andthe plane perpendicular to the central longitudinal axis 4940. In someembodiments, the angle θ_(t) is between about 0° and about 90°. Athigher transition angles θ_(t), the amount of bulging is higher, and, atlower transition angles θ_(t), the amount of bulging is lower. A highertransition angle θ_(t) may enhance torsional rasping of hard clotsadherent to the vessel endothelium. A lower transition angle θ_(t) mayenhance wall apposition of flow diverters or flow disruptors in thetreatment of aneurysms or vascular malformations. Referring again toFIGS. 10H and 10I, a schematic representation of the measurement oftransition angle θ_(t) is shown. In the embodiment illustrated in FIG.10H, the transition angle θ_(t) is about 20°. In the embodimentillustrated in FIG. 10I, the transition angle θ_(t) is about 75°.

FIG. 10J is a schematic side elevational view of another exampleembodiment of a woven tubular structure 158 around a mandrel 175. Insome embodiments, bangles or c-shaped clamps 190 may be used to tightenthe textile structure 158 around the mandrel 175 instead of or inaddition to the wire 180, 182. FIG. 10J illustrates the textilestructure 158 being tightened around the mandrel 175 using bangles orc-shaped clamps 187, instead of wire, between the two large sphericalbulbs 179 near one end of the woven tubular structure 158 and usingbangles or c-shaped clamps 189 between the medium spherical bulb 178 andthe left large spherical bulb 179, instead of wire, near the other endof the woven tubular structure 158. The bangles 190 may include a slit191 that allows the bangle 190 to be pried open and wrapped around thetextile structure 158 and the mandrel 175 but small enough thatfilaments of the textile structure 158 generally cannot protrude out ofthe slit 191.

FIG. 10K is a schematic side elevational view of yet another exampleembodiment of a woven tubular structure 158 around a mandrel 5300. FIG.10K illustrates the textile structure 158 being tightened around themandrel 5300 including the strand 172 using three different types ofbangles or c-shaped clamps 5305, 5307, 5309 and wire 5303 to formdiscrete valleys and discrete hills in the region of the bulbs 177 and178. In some embodiments, the bangle has a length close to that of theneck. In some embodiments, the bangle is thin enough that a plurality ofbangles may be placed between the bulbs 174. In some embodiments asillustrated in FIG. 10K, circumferential ends of the bangles or c-shapedclamps may be circumferentially spaced by a slit 191 as shown by thebangle 5305, abut as shown by the bangle 5307, longitudinally overlap orcircumferentially overlap as shown by the bangle 5309, etc. In someembodiments, temporary high-temperature adhesive may be used instead ofor in addition to mechanical fasteners such as wire and/or bangles.

The textile structure 158 to the left of the left bulb 176 or thedistal-most bulb may also be secured to the strand 172 to form thedistal neck 65. The portions of the strand 172 beyond the bulbs 174 mayinclude markers to help determine the length of any proximal and distalnecks. In some embodiments, the distal neck 65 may be curled, forexample into a pigtail (e.g., by curling the strand 172 to the left ofthe left bulb 176).

In some embodiments, the strand 172 may be substantially omitted. Forexample, the bulbs 174 can be placed inside the textile structure 158and then the textile structure 158 tightened around each side of thebulbs 174. An external template, for example, may be used to ensureproper spacing. Such a method may increase adaptability for formingdifferent types of distal portions 100 using the same bulbs 174. In someembodiments, the strand 172 may be removed from the bulbs 174 aftersecuring the textile structure 158 around the bulbs 174.

The textile structure 158 and the bulbs 174, and optionally the strand172, are heat treated to impart shape memory to at least some of thefilaments (e.g., at least the filaments 156 comprising shape memorymaterial). In some embodiments, the secondary heat treatment of shapememory (e.g., comprising between about 55.8 wt % and about 57 wt %nickel) is at a temperature between about 500° C. and about 550° C.(e.g., about 525° C.) for between about 3 minutes and about 10 minutes(e.g., about 5 minutes) in an atmosphere (e.g., a sand bath fluidizedwith ambient air). As described herein, certain such heat treatmentprocesses can maintain the shape of the distal portion 100 (e.g.,including the bulbs and necks) between at least about room temperatureand about body temperature absent stress-induced martensite, for examplebecause the austenitic finish temperature A_(f) is between about 10° C.and about 18° C. (e.g., the distal portion 100 is super-elastic attemperatures greater than about 18° C.).

In some embodiments, the secondary heat treatment of shape memory (e.g.,comprising between about 54.5 wt % and about 55.3 wt % nickel) is at atemperature between about 400° C. and about 450° C. (e.g., about 425°C.) for between about 3 minutes and about 10 minutes (e.g., about 5minutes) in an atmosphere (e.g., a sand bath fluidized with ambientair). As described herein, certain such heat treatment processes canmaintain the shape of the distal portion 100 (e.g., including the bulbsand necks) between at least about room temperature and about bodytemperature absent stress-induced martensite, for example because theaustenitic finish temperature A_(f) is between about 10° C. and about18° C. (e.g., the distal portion 100 is super-elastic at temperaturesgreater than about 18° C.).

In some embodiments, the secondary heat treatment of shape memory (e.g.,comprising between about 55.8 wt % and about 57 wt % nickel) is at atemperature between about 400° C. and about 450° C. (e.g., about 425°C.) for between about 3 minutes and about 10 minutes (e.g., about 5minutes) in an atmosphere (e.g., a sand bath fluidized with ambientair). Certain such heat treatment processes can maintain the tubularshape of the distal portion 100 (e.g., without the bulbs and necks)between at least about room temperature and about body temperatureabsent stress-induced martensite, for example because the austeniticfinish temperature A_(f) is increased from between about 10° C. andabout 18° C. to between about 25° C. and about 37° C. (e.g., the distalportion 100 slowly transitions to the bulb and neck shape attemperatures between about 25° C. and 37° C.). This dual heat treatmentand slow shape transformation at room and/or body temperature can bereferred to as one-way shape memory effect.

In some embodiments, the secondary heat treatment of shape memory (e.g.,comprising between about 54.5 wt % and about 55.3 wt % nickel) is at atemperature between about 500° C. and about 550° C. (e.g., about 525°C.) for between about 20 minutes and about 180 minutes (e.g., about 25minutes) in an atmosphere (e.g., a sand bath fluidized with ambientair). Certain such heat treatment processes can maintain the tubularshape of the distal portion 100 (e.g., without the bulbs and necks)between at least about room temperature and about body temperatureabsent stress-induced martensite, for example because the austeniticfinish temperature A_(f) is increased from between about 10° C. andabout 18° C. to between about 25° C. and about 37° C. (e.g., the distalportion 100 slowly transitions to the bulb and neck shape attemperatures between about 25° C. and 37° C.).

In some embodiments, the secondary heat treatment of shape memory (e.g.,comprising between about 55.8 wt % and about 57 wt % nickel) is at atemperature between about 400° C. and about 450° C. (e.g., about 425°C.) for between about 3 minutes and about 10 minutes (e.g., about 5minutes) in an atmosphere (e.g., a sand bath fluidized with ambientair), which can have the effect described above. In some embodiments, atertiary heat treatment may be performed, for example to impart theshape of the distal portion 100 shown in FIG. 27L at certaintemperatures. In certain such embodiments, the tertiary heat treatmentof shape memory (e.g., comprising between about 55.8 wt % and about 57wt % nickel) is at a temperature between about 500° C. and about 550° C.(e.g., about 525° C.) for between about 3 minutes and about 10 minutes(e.g., about 5 minutes) in an atmosphere (e.g., a sand bath fluidizedwith ambient air). Certain such heat treatment processes can maintainthe spiral or twisted or helical shape of the distal portion 100 betweenabout 10° C. and about 18° C. absent stress-induced martensite, whichcan be achieved in a body, for example, by injecting cold saline (e.g.,between about 5° C. and about 18° C.) for a localized temperature changeor cooling effect. This triple heat treatment can be referred to astwo-way shape memory effect.

In some embodiments, the secondary heat treatment of shape memory (e.g.,comprising between about 54.5 wt % and about 55.3 wt % nickel) is at atemperature between about 500° C. and about 550° C. (e.g., about 525°C.) for between about 20 minutes and about 180 minutes (e.g., about 25minutes) in an atmosphere (e.g., a sand bath fluidized with ambientair), which can have the effect described above. In some embodiments, atertiary heat treatment may be performed, for example to impart theshape of the distal portion 100 shown in FIG. 27L at certaintemperatures. In certain such embodiments, the tertiary heat treatmentof shape memory (e.g., comprising between about 54.5 wt % and about 55.3wt % nickel) is at a temperature between about 400° C. and about 450° C.(e.g., about 425° C.) for between about 3 minutes and about 10 minutes(e.g., about 5 minutes) in an atmosphere (e.g., a sand bath fluidizedwith ambient air). Certain such heat treatment processes can maintainthe spiral or twisted or helical shape of the distal portion 100 betweenabout 10° C. and about 18° C. absent stress-induced martensite, whichcan be achieved in a body, for example, by injecting cold saline (e.g.,between about 5° C. and about 18° C.) for a localized temperature changeor cooling effect.

The secondary and/or tertiary heat treatment temperature can be adjustedbased on the particular shape-memory alloy. For example, a ternary alloycomprising cobalt may exhibit properties similar to a relatively lownickel shape-memory alloy.

In some embodiments, after heat treating, the distal portion is thenplaced in a water bath (e.g., between about 20° C. and about 25° C.) forbetween about 15 minutes and 45 minutes (e.g., about 30 minutes). Rapidheating and/or cooling can help to retain the shape (e.g., to achievethe austenite finish temperature A_(f)). After this second heattreatment, the textile structure 158 may be referred to as a secondaryheat set or shape set structure.

FIG. 10L is a schematic side elevational view of an example embodimentof removal of a mandrel from a woven tubular structure 158. The wire,bangles, adhesive, etc. has been removed after heat treating to impartthe shape of the mandrel to the textile structure. The mandrel includesa first mandrel piece 5010 and a second mandrel piece 5020. The firstmandrel piece 5010 is shown being removed from one side (proximal ordistal), as indicated by the arrow 5025, and the second mandrel piece5020 is shown being removed from the other side, as indicated by thearrow 5030 (e.g., by being separable in an intermediate portion betweenthe first mandrel piece 5010 and the second mandrel piece 5020). In someembodiments, after heat treatment, removing the mandrel piece 5020including the proximal four spherical bulbs in the proximal directionand removing the mandrel piece 5010 including the distal six sphericalbulbs 5010 in the distal direction may inhibit damage to the integrityof the woven tubular structure 158. A one piece mandrel or a multiplepiece mandrel may also be removed from one side. Although some examplesof mandrels are provided herein, some embodiments of mandrels mayinclude a wide variety of different bulb parameters such as bulbquantity, shape, size, spacing, phase-shifting with regards to thelongitudinal axis or to a chord of the axis, material parameters,different neck parameters (e.g., neck diameter, neck length, etc.),alignment to the longitudinal axis or to a chord of the axis, number ofmandrels, combinations thereof, and the like.

The primary heat treatment in the cylindrical shape can allow the bulbsto radially expand to at least the diameter of the mandrel 162 withoutbeing damaged, and the secondary heat treatment can provide shapesetting. In some embodiments, the first heat treatment process may beomitted (e.g., the textile structure 158 slid off the mandrel 162 andthen onto the mandrel 170 (e.g., secured with wires, bangles, adhesive,etc.) with no primary heat treatment).

FIG. 10M is a schematic partial cut away side view of an exampleembodiment of heat treatment device. In some embodiments, the heattreatment device comprises a fluidized sand bath 5400. The fluidizedsand bath 5400 includes an outer wall 5410 and an inner thermalinsulation layer 5430. The fluidized sand bath 5400 includes aconstrictive air inlet gate 5455 that allows the inflow of ambient airfor heat treatment at atmosphere, or inflow of select gases (e.g.,nitrogen, a mixture of hydrogen and nitrogen, a mixture of carbonmonoxide, hydrogen, and nitrogen, combinations thereof, and the like)for heat treatment in an inert atmosphere. In some embodiments, the heattreatment is performed in a fluidized sand bath 5400 in inert atmosphereto inhibit oxidation of the surface of shape memory material, forexample to inhibit formation of nickel oxides in alloys of nickel andtitanium, during heat treatment.

In some embodiments, the heat treatment device 5400 includes an externalair inflow regulator 5450 having an adjustable height h₁, which canregulate the velocity of the air inflow into the inner chamber 5415 ofthe sand bath 5400 through the constrictive air inlet gate 5455, tocreate an adequate fluidized state in the sand bath 5400. The externalair inflow regulator 5450 is at a height h₁ above the ground, which canbe adjusted by increasing or decreasing the height h₁, has a pressureP₁, and a velocity of gas v₁. The gas 5425 entering the inner chamber5415 of the sand bath 5400 through the constrictive air inlet gate 5455is at a height h₂ above the ground, has a pressure P₂, and a velocity ofgas v₂. As the sum of the kinetic energy per unit volume ½ρv²), thepotential energy per unit volume (ρgh), and the pressure energy (P)remain the same, the density of the gas ρ and the acceleration due togravity g (980 cm/second²) remain constant, the velocity of the gas v₂entering the inner chamber 5415 of the sand bath 5400 can be calculatedusing Equation 1:½ρv ₁ ² +ρgh ₁ +P ₁=½ρv ₂ ² +ρgh ₂ +P ₂  (Eq. 1)or, rearranged, v ₂ =√[v ₁ ²+1960(h ₁ −h ₂)+2(P ₁ −P ₂)/ρ]

In some embodiments, if the pressures P₁ and P₂ are equal to atmosphericpressure (P₁=P₂=P_(atm)), the height h₂ of the constrictive air inletgate 5455 is at ground level (h₂=0), and the gas velocity at the levelof the external air inflow regulator 5450 is initially at rest (v₁=0),then the velocity v₂ of the gas entering the inner chamber 5415 of thesand bath 5400 is directly proportional to the height h₁ of the externalair inflow regulator 5450. By increasing the height h₁ of the externalair inflow regulator 5450, the velocity v₂ of the gas can be increased,and v₂ can be calculated in cm³/s using Equation 2:v ₂=√(1960×h ₁)  (Eq. 2)

In some embodiments, the sand bath 5400 includes a fail safe temperatureregulator 5460 and an electric energy regulator 5465. The fail safetemperature regulator 5460 can help regulate the temperature within thefluidized sand bath 5400. For example, during the heat treatment of analloy of nickel and titanium, if the temperature is above 550° C., thefail safe temperature regulator 5460 may turn off the air inlet gate5455 or, through the electric energy regulator 5465, turn off the powerto a heating element 5440, as elevated annealing temperatures mayadversely impact the A_(f) temperature as discussed herein. In someembodiments, the electric energy regulator 5465 can help regulate thevoltage (AC or DC voltages) to inhibit electrical surges that mayincrease or decrease the temperature of the fluidized sand bath 5400through the heating element 5440. For example, if an electrical surgeduring the heat treatment of an alloy of nickel and titanium impactedthe heating element 5440 and increased the temperature above 550° C.,the electric energy regulator 5465 may turn off the power to the heatingelement 5440, as elevated annealing temperatures may adversely impactthe A_(f) temperature as discussed herein. In some embodiments, the failsafe temperature regulator 5460 and the electric energy regulator 5465may be controlled and regulated by sensors, for example thermal sensors,pressure sensors, electrical sensors, combinations thereof, and thelike.

In the example embodiment illustrated in FIG. 10M, the gas 5425 thatenters through the air inlet gate 5455 passes through a porous plate5445 and a heating element 5440 prior to entering the inner chamber 5415of the sand bath 5400. The heating element 5440 may be electricallycontrolled and regulated via the fail safe temperature regulator 5460and/or the electric energy regulator 5465. The inner chamber 5415 of thesand bath 5400 includes sand bath media 5420, for example dry inertnon-flammable particles such as alumina (aluminum oxide), metallic beadssuch as stainless steel, combinations thereof, and the like. Fluidizedsand bath media or particles 5420 may have a melting point and/orboiling point well above the heat treatment temperature such thatsolidification, which could otherwise occur upon on cooling (e.g., as insalt baths) and fumes (e.g., as in hot oil baths) are inhibited.

In the embodiment illustrated in FIG. 10M, when the gas 5425 is passedthrough the sand bath media or particles (e.g., aluminum oxideparticles) 5420 via the porous plate 5445 and the heating element 5440,the sand bath media 5420 are separated and suspended in the gas flow5425 and take on the appearance of a boiling liquid with excellent heattransfer characteristics. When the fluidized sand bath media 5420 areheated, heat is distributed quickly and evenly throughout the sand bath5400 and transferred rapidly to any devices or components 5435 in thesand bath 5400.

In some embodiments, the fluidized sand bath 5400 comprises a detachableflange 5405 that covers the roof of the sand bath 5400. The detachableflange 5405 of FIG. 10M includes a handle 5487 and one or more hollowconduits 5475 to allow passage of the arms of the container or basket5470 carrying the devices or components 5435 being heat treated. Thecontainer 5470 may take a variety of shapes, for example, sphere,oblong, egg, oval, ellipse, helical, triangle, rectangle, parallelogram,rhombus, square, diamond, pentagon, hexagon, heptagon, octagon, nonagon,decagon, trapezoid, trapezium, other polygons, or bulged versions ofthese and other shapes, combinations thereof, and the like, based on thedevices or components 5435 being heat treated. The arms of the container5470 may include single filament wires, multi-filament wires, hypotubes,combinations thereof, and the like. In some embodiments, the arms of thecontainer 5470 are reversibly attached to the flange 5405 via detachableair-sealant rivets 5480 on the outside of the flange 5405, in which casethe arms of the container 5470 pass through the hollow conduits 5475, onthe inside of the flange 5405, in which case the arms of the container5470 do not pass through the hollow conduits 5475, or on both the insideand the outside of the flange 5405. The reversible attachment points ofthe arms of the container 5470 to the air-sealant rivets 5480 mayinclude a luer lock mechanism, a ball and socket mechanism, a wire andhook mechanism, a c-shaped clasp and hook mechanism, combinationsthereof, and the like. The detachable flange 5405 can allow placement ofthe container 5470 with the devices or components 5435 being heattreated in the fluidized sand bath 5400 and/or removal of the container5470 and the devices or components 5435 from the fluidized sand bath5400 for placement in the cooling bath after heat treatment.

FIG. 11A is a schematic side elevational view of an example embodimentof braiding around a mandrel 162. For example, FIG. 11A schematicallyshows what is occurring in FIGS. 8A and 8D. The mandrel 162 may be usedin a heat treatment process to impart a cylindrical shape, or thetextile structure may be slid off of the mandrel 162 for heat treatmenton another mandrel.

FIG. 11B is a schematic side elevational view of another exampleembodiment of braiding around a mandrel 5600. The mandrel 5600 includesbulbs 174 and strand 172, for example as describe with respect to FIGS.10C and 10D. The textile structure 158 may be braided around the mandrel5600 so that woven bulbs 5610 are formed during the braiding process,for example the woven bulbs 5612, 5614 with a woven neck 5620 betweenthe woven bulbs 5612, 5614. The textile structure 158 may be heattreated on the mandrel 5600 to impart the bulb shapes, reducingmanufacturing steps compared to a two-step heat treatment. During orafter the braiding process, bangles, wire, adhesive, etc. may be used tosecure portions of the textile structure more tightly to the mandrel5600, for example as described with respect to FIGS. 10G, 10J, and 10K.In some embodiments, a single heat treatment after braiding around abulbous mandrel 5600 as illustrated in FIG. 11B may include the sameparameters as the second heat treatment around the mandrel 170 asdescribed above.

FIG. 11C is a schematic side elevational view of an example embodimentof forming a textile structure. The textile structure 158 may form adistal portion of a vascular treatment device, for example of the distalportion 100 of the device 10, 20, 30, or 40. For example as describedwith respect to FIG. 8A and/or FIG. 9B, the braiding device 5700includes a yarn wheel or braid carrier mechanism or circular horn gear152 and a plurality of spindles 153 and individual carriers 155. Aspindle 153 is a stick on the circular horn gear 152. A spool 154 is ahollow device that fits onto a spindle 153 and includes filaments 156wound around it. An individual carrier 155 includes a spindle 153 and aspool 154 on the spindle 153. The terms spindle, spool, and individualcarrier may be used interchangeably depending on context. The individualcarriers 155 include spools 154 including filaments 156 that are woventogether to form the textile structure 158 of the distal portion 100.The filaments 156 each extend from a individual carrier 155 to a ring orvertical puller 161 over a bulbous mandrel 5710 comprising sphericalbulbs (e.g., the mandrel 5600 of FIG. 11B), and are braided around thebulbous mandrel 5710 by spinning the circular horn gear 152, spinningthe spindles 153, and pulling the ring 161 away from the circular horngear 152 in a vertical direction 164. As the textile structure 158 iswoven at preform point 160, the textile structure 158 advances in thedirection of the arrow 164. The circular horn gear 152 spins in thedirection of the arrows 166 in a horizontal plane, and the spools 154including filaments 156 on the spindles 153 rotate within the circularhorn gear 152 to create the desired braiding pattern including pluralityof woven bulbs 174, which includes in this example two large sphericalbulbs 179 and two medium spherical bulbs 178, and necks between thebulbs 174. Although some examples of the carrier braider 150 with 4spindles 153 or individual carriers 155 are provided herein, someembodiments of the carrier braider 150 may include 6 to 144 spindles 153or individual carriers 155 in accordance with the values provided aboveand/or carrier braiders 150 that have 6, 12, 24, 36, 48, 60, 72, 84, 96,120, 144, etc. spindles 153 or individual carriers 155. The textilestructure 158 may be heat treated on the mandrel 5710 to impart the bulbshapes, reducing manufacturing steps compared to a two-step heattreatment. In some embodiments, a single heat treatment after braidingaround a bulbous mandrel 5710 as illustrated in FIG. 11C may include thesame parameters as the second heat treatment around the mandrel 170 asdescribed above.

FIG. 11D is a schematic side elevational view of another exampleembodiment of forming a textile structure 158. The textile structure 158may form a distal portion of a vascular treatment device, for example ofthe distal portion 100 of the device 10, 20, 30, or 40. For example asdescribed with respect to FIG. 8A, FIG. 9B, and/or FIG. 11C, thebraiding device 5800 includes a yarn wheel or braid carrier mechanism orcircular horn gear 152 and a plurality of spindles 153 and individualcarriers 155. A spindle 153 is a stick on the circular horn gear 152. Aspool 154 is a hollow device that fits onto a spindle 153 and includesfilaments 156 wound around it. An individual carrier 155 includes aspindle 153 and a spool 154 on the spindle 153. The terms spindle,spool, and individual carrier may be used interchangeably depending oncontext. The individual carriers 155 include spools 154 includingfilaments 156 that are woven together to form the textile structure 158of the distal portion 100. Each spindle pair 5720 includes an outerspindle or individual carrier 5717 and an inner spindle or individualcarrier 5715. The filaments 156 each extend from an individual carrier155 to a ring or vertical puller 161 over a bulbous mandrel 5710comprising spherical bulbs (e.g., the mandrel 5600 of FIG. 11B), and arebraided around the bulbous mandrel 5710 by spinning the circular horngear 152, spinning the spindles 153, and pulling the ring 161 away fromthe circular horn gear 152 in a vertical direction 164. As the textilestructure 158 is woven at preform point 160, the textile structure 158advances in the direction of the arrow 164. The circular horn gear 152spins in the direction of the arrows 166 in a horizontal plane, and thespools 154 including filaments 156 on the spindles 153 rotate within thecircular horn gear 152 to create the desired braiding pattern includinga plurality of woven bulbs 174, which in this example includes two largespherical bulbs 179 and two medium spherical bulbs 178, and necksbetween the bulbs 174. The textile structure 158 may include a pluralityof segments, at least one of the segments having a different pore sizethan at least one other segment. For example, in the textile structure158 illustrated in FIG. 11D, the distal segment 5810 has relatively highPPI and has relatively low porosity, the middle segment 5820 hasrelatively low PPI and has relatively high porosity, and the proximalsegment 5830 has relatively high PPI and has relatively low porosity.Although some examples of the carrier braider 150 with 4 spindles 153 orindividual carriers 155 are provided herein, some embodiments of thecarrier braider 150 may include 6 to 144 spindles 153 or individualcarriers 155 in accordance with the values provided above and/or carrierbraiders 150 that have 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, etc.spindles 153 or individual carriers 155. The textile structure 158 maybe heat treated on the mandrel 5710 to impart the bulb shapes, reducingmanufacturing steps compared to a two-step heat treatment. In someembodiments, a single heat treatment after braiding around a bulbousmandrel 5710 as illustrated in FIG. 11D may include the same parametersas the second heat treatment around the mandrel 170 as described above.

FIG. 11E is a perspective view of an example embodiment of a distalportion 5900 of a vascular treatment device, for example the result ofthe braiding process illustrated in FIG. 11D. Referring again to FIGS.2B and 2C, the distal portion 5900 in FIG. 11E comprises a plurality ofwoven bulbs (1112, 1114, 1116, and 1118) and woven necks similar to thedistal portion 1100 in FIGS. 2B and 2C, with a modification beingsegments 5810, 5820, 5830, 5840 having variable pore size. In someembodiments, the braid carrier mechanism 2600 setup illustrated in FIG.9C can form a braiding pattern of the distal portion 158 as shown inFIG. 11E, in which the distal segment 5810, for example, has arelatively high PPI and has relatively low porosity. If the “Start-Stop”capability is activated after the braiding the distal segment 5810, andonce the vertical puller or ring 161 is stopped to allow the spools 154including filaments 156 to be rearranged between one spindle 153 andanother spindle 153 in a symmetric pattern or an asymmetric pattern byincreasing the number of empty spindle pairs, for example the braidcarrier mechanism 2650 setup illustrated in FIG. 9D, the middle segment5820 can have a relatively low PPI and can have relatively highporosity.

In some embodiments, if the “Start-Stop” capability is activated againafter braiding the middle segment 5820, and once the vertical puller orring 161 is stopped to allow the spools 154 including filaments 156 tobe rearranged between one spindle 153 and another spindle 153 in anotherpattern, for example back to the braid carrier mechanism 2600 setupillustrated in FIG. 9C, the proximal segment 5830 can have a relativelyhigh PPI and can have relatively low porosity. Higher PPI can result ina smaller pore size, which can decrease flow into an aneurysm or avascular malformation such as an arterio-venous fistula, which can aidin thrombosis of the aneurysm or vascular malformation or serve tofilter any debris or emboli that may be released during thrombectomy. Insome embodiments, by alternating between the arrangements of the braidcarrier mechanism illustrated in FIGS. 9C and 9D, low porosity and/orhigh porosity segments of the distal portion can be achieved.

Referring again to FIG. 10L, for example, after the textile structure158 has been removed from the mandrel 170 after the second heattreatment, the proximal and distal ends may be trimmed to a desiredsize. For example, precise or approximate proximal and distal necks maybe formed by laser cutting, or mechanically cutting a certain distancefrom a proximal-most or distal-most bulb. In some embodiments, thedistal portion 100 has a total length greater than about 60 mm. In someembodiments, the filaments are sheared using a device similar to a polepruner. The ends may be trimmed transverse to the longitudinal axis orat an angle. The filaments may be trimmed individually, or two or morefilaments (including all or substantially all of the filaments) may betrimmed at substantially the same time (e.g., with a single cuttingstroke or motion). The cross-section of the ends of the filaments maydepend at least partially on the trim angle and the angle of thebraiding pattern at the trim point. The trimmed ends may be furthertreated or left as is.

FIG. 12A is a schematic perspective view of an example embodiment of afilament end treatment of a distal portion 6000 of a vascular treatmentdevice. The distal portion 6000 may be the distal portion 100 of thedevice 10, 20, 30, or 40. The part of the distal portion 6000 shown inFIG. 12A is the distal neck 65, but could also or alternatively be awide mouth distal section, a proximal neck, a wide mouth proximalsection, etc. For illustration purposes, the distal portion 6000includes 12 woven filaments 156, although end treatments describedherein may be suitable for higher or lower quantities of filaments 156.FIG. 12B is a front elevational view of the filament end treatment ofFIG. 12A. The filament end treatment illustrated in FIGS. 12A and 12Bincludes leaving the ends of the filaments 156 as is or untreated afterthey have been trimmed.

FIG. 12C is a schematic perspective view of another example embodimentof a filament end treatment of a distal portion 6100 of a vasculartreatment device. The distal portion 6100 may be the distal portion 100of the device 10, 20, 30, or 40. The part of the distal portion 6100shown in FIG. 12C is the distal neck 65, but could also or alternativelybe a wide mouth distal section, a proximal neck, a wide mouth proximalsection, etc. For illustration purposes, the distal portion 6100includes 12 woven filaments 156, although end treatments describedherein may be suitable for higher or lower quantities of filaments 156.FIG. 12D is a front elevational view of the filament end treatment ofFIG. 12C. The filament end treatment illustrated in FIGS. 12C and 12Dincludes dip-coating or spray coating the distal neck 65 with a polymer.The polymer may comprise a biomedical polymer, for example silicone,polyurethane (e.g., Polyslix, available from Duke Extrusion of SantaCruz, Calif.), polyethylene (e.g., Rexell®, available from Huntsman)including low density polyethylene (LDPE), linear low densitypolyethylene (LLDPE), medium density polyethylene (MDPE), and highdensity polyethylene (HDPE), fluoropolymers such as fluorinated ethylenepropylene, PFA, MFA, PVDF, THV, ETFE, PCTFE, ECTFE (e.g., Teflon® FEP,available from DuPont), polypropylene, polyesters including polyethyleneterephthalate (PET), PBT, PETG (e.g., Hytrel®, available from DuPont),PTFE, combination polymer compounds such as thermoplastic polyurethanesand polyether block amides (e.g., Propell™ available from FosterCorporation of Putnam, Conn.), polyether block amides (e.g. Pebax®available from Arkema of Colombes, France, PebaSlix, available from DukeExtrusion of Santa Cruz, Calif.), polyether soft blocks coupled withpolyester hard blocks vinyls such as PVC, PVDC, polyimides (e.g.,polyimides available from MicroLumen of Oldsmar, Fla.), polyamides(e.g., Durethan, available from Bayer, Nylon 12, available from DukeExtrusion of Santa Cruz, Calif.), polycarbonate (e.g., Corethane™,available from Corvita Corp. of Miami, Fla.), styrenics such as PS, SAN,ABS, and HIPS, acetals such as copolymers or homopolymers, PLA, PGA,PLGA, PCL, polyorthoesters, polyanhydrides, and copolymers thereof, hightemperature performance polymers such as PEEK, PES, PPS, PSU, LCP,combinations thereof, and the like. In some embodiments, the polymer mayinclude a radiopaque material (e.g., particles of radiopaque materialdispersed in the polymer). In some embodiments, masking a portion of theend section of the distal portion 6100 during dip coating or spraycoating can inhibit polymer from depositing in the area of masking. Forexample, if the distal portion 6100 is dip coated or spray coated whilestill on the mandrel 170, the polymer may be inhibited from beingdeposited on the inside of the distal portion 6100, which can preservethe inner lumen and maintain an inner diameter of the distal portion6100. In some embodiments, dip coating or spray coating prior totrimming the ends of the filaments 156 is also possible. In certain suchembodiments, the polymer may maintain the position of the filaments 156so that they are not frayed. The coated end section may then be trimmedand left as is or further coated. For example, the end section may bespray coated on the mandrel 170, trimmed, and then dip coated.

In some embodiments, coating may include coating radiopaque material(e.g., particles of iridium, platinum, tantalum, gold, palladium,tungsten, tin, silver, titanium, nickel, zirconium, rhenium, bismuth,molybdenum, combinations thereof, and the like, and/or other radiopaqueagents such as barium sulfate, tungsten powder, bismuth subcarbonate,bismuth oxychloride, iodine containing agents such as iohexyl (e.g.,Omnipaque™, available from Amersham Health, a division of GEHealthcare), etc.) The radiopaque material may be coated after thepolymer, along with the polymer, and/or interspersed with the coating ofthe polymer. The filaments 156 may be cut in a manner that reducesfraying (e.g., laser cut) since a coating a frayed filament 156 mayresult in a coated but still frayed filament 156.

Referring again to FIGS. 12C and 12D, at least the distal end of thedistal neck 65 is coated with polymer 6110. In some embodiments, thepolymer 6110 covers about 10% to about 75% (e.g., about 25% to about50%) of the length of the distal neck 65. In some embodiments, thepolymer 6110 covers about 0.5 mm to about 3 mm (e.g., about 1 mm toabout 2 mm) of the length of the distal neck 65. More or less polymer6110 can be used depending on the size of the distal portion 6100 and/orthe distal neck 65.

FIG. 12E is a schematic perspective view of yet another exampleembodiment of a filament end treatment of a distal portion 6200 of avascular treatment device. The distal portion 6200 may be the distalportion 100 of the device 10, 20, 30, or 40. The part of the distalportion 6200 shown in FIG. 12E is the distal neck 65, but could also oralternatively be a wide mouth distal section, a proximal neck, a widemouth proximal section, etc. The filament end treatment illustrated inFIG. 12E includes coupling a radiopaque marker band 6210 to the distalend of the distal neck 65. In some embodiments, the material of theradiopaque marker band may include metals or alloys, including but notlimited to iridium, platinum, tantalum, gold, palladium, tungsten, tin,silver, titanium, nickel, zirconium, rhenium, bismuth, molybdenum,combinations thereof, and the like.

FIG. 12F is a schematic perspective view of still another exampleembodiment of a filament end treatment of a distal portion 6300 of avascular treatment device. The distal portion 6300 may be the distalportion 100 of the device 10, 20, 30, or 40. The part of the distalportion 6300 shown in FIG. 12F is the distal neck 65, but could also oralternatively be a wide mouth distal section, a proximal neck, a widemouth proximal section, etc. The filament end treatment illustrated inFIG. 12F includes dip coating or spray coating with a polymer 6110 atleast the distal end of the distal neck (e.g., as described with respectto FIGS. 12C and 12D) and coupling a radiopaque marker band 6210 to thedistal end of the distal neck 65 (e.g., as described with respect toFIG. 12E).

Coating the ends of the distal portion 100 can inhibit the end fromfraying and/or inhibit frayed ends from puncturing body tissue. The endsof the distal portion can be left loose, for example in embodiments inwhich the small size of the filaments allows them to be flexible enoughto be unlikely to puncture tissue. Omission of a polymer tip (e.g., withno further processing or, for example, by coupling a radiopaque markerband without polymer) can allow the distal portion 100 to be sterilizedusing gamma radiation, which could damage polymers such as polyurethaneand which is generally less expensive than chemical sterilizationtechniques such as ethylene oxide sterilization.

In some embodiments, the distal portion 100 includes a braided structure(e.g., produced by intertwining or interlacing two or more filamentsdiagonal or at an angle to the longitudinal or production axis of thedistal portion 100). Woven structures are not limited to those in whichthe filaments are oriented at about 90° angles to each other.

In some embodiments, the distal portion 100 includes a knitted structure(e.g., produced by interlocking a series of loops of the filaments tocreate the distal portion 100). FIG. 13A is a photograph illustrating anexample embodiment of a plurality of filaments 11830 being formed intoan example biomedical textile structure 11825. In contrast to sometextile structures 158 described herein, the structure 11825 illustratedin FIG. 13A includes one or more filaments 11830 being transverse to thelongitudinal axis, which can result in poor radial force, poor wallapposition, and poor clot capture, along with having poor filteringability (e.g., due to low porosity), but can allow longitudinal crowdingto permit varying pore size during deployment. The size of pores of thetextile structure 11825 may be substantially uniform over a large area.In some embodiments, at least a segment of the distal portion 100includes knitting.

FIG. 13B is a photograph illustrating an example embodiment of aplurality of filaments 11845 being woven into another example biomedicaltextile structure 11835. In contrast to some other textile structures158 described herein, the structure 11835 illustrated in FIG. 13B is notformed as a cylinder, but is knitted as a sheet, here characterized byinterlocking loops. The sheet 11835 may then be rolled into a cylinderand heat treated, mechanically fixed, etc. to impart the cylindricalstructure, and the cylinder may then be wrapped around a bulbousmandrel, for example as described with respect to FIG. 10D. The sheetmay be wrapped directly around a bulbous mandrel (e.g., without firstbeing shape set into a cylinder), reducing manufacturing steps. A rolledsheet may include stray filaments along an entire length of the distalportion 100, which may be advantageous for scraping some plaques orother such usages. The size of pores 11840 of the textile structure11835 may be substantially uniform over a large area. Knitting intotubular shapes is also possible (e.g., weft knitting).

In some embodiments, after removal from a bulbous mandrel, the distalportion 100 does not include a crimping element around the necks orbetween the bulbs. In some embodiments, after removal from a bulbousmandrel, the distal portion 100 does not include a central wire or anyother inner member such as an actuation member, other than the filamentsused to form the shape-set textile structure (e.g., the bulbs and necksare hollow). In some embodiments, the distal portion 100 does notinclude radiopaque markers (e.g., marker bands), which can reduce acollapsed profile of the distal portion 100. In some embodiments, atleast one bulb of the distal portion 100 (e.g., the distal-most bulb) islarger than an aneurysm and/or a mouth of an aneurysm (e.g., in contrastto balls woven for the sole purpose of insertion into an aneurysm). Insome embodiments, the distal portion is configured to capture a thrombusbetween undulations (e.g., between hills and valleys created by bulbsand necks and/or between crossing filaments) such that an interiorvolume of the distal portion 100 (e.g., radially inward of the necks andbulbs) is not configured to receive a thrombus.

Distal portions 100 are generally described herein as integralstructures in which the same filaments form all of the bulbs and necks.In some embodiments, the distal portion 100 may include a plurality ofwoven textile structures coupled to each other. For example, eachtextile structure may include one bulb, a plurality of bulbs having thesame size or different sizes, a plurality of bulbs having the same shapeor different shapes, etc. Certain such embodiments can enablemanufacturing of a plurality of woven textile structures at one time,and at a later time assembling distal portions 100 from selected woventextile structures.

The distal portions described above may also constitute an entirevascular or other body lumen treatment device. For example, the distalportions may be a deployable endoprosthesis or stent, part of a vasculartreatment device such as an intermediate or proximal portion, etc. Theendoprosthesis may be coupled to a proximal portion 200 or other devicedetachable joint (e.g., Guglielmi electrolytic detachment, mechanicaldetachment (e.g., as described herein), etc.).

The distal portion 100 can be coupled to a proximal portion 200 at ajoint 300, as described in further detail herein. In some embodiments,only the distal end of the distal portion 100 is coupled to the proximalportion at the joint 300. In some embodiments, the proximal end of thedistal portion 100 is not coupled, joined, affixed, adhered, bonded,etc. to the proximal portion 200.

FIG. 14A is a photograph of an example of a segment of an exampleembodiment of a proximal portion 200 of a vascular treatment device.FIG. 14B is a photograph of another example segment of an exampleembodiment of a proximal portion 200 of a vascular treatment device.FIG. 12B also includes a United States penny ($0.01 or 1¢) to provide arough, non-limiting, sizing of an example distal portion 200 and itskerfs 204. The proximal portion 200 comprises a tubular structure 202and a plurality of openings (slits, kerfs, cuts, incisions, etc.) 204.FIG. 14A also shows a heat impact puddle 207, for example as describedherein with respect to FIG. 17B. As used herein, the term kerf shall begiven its ordinary meaning and shall include slits, slots, and otheropenings that typically extend completely through a wall (e.g.,sidewall), but may also partially extend into a wall (e.g., notches,grooves, etc.). In some embodiments, the tubular structure 202 comprisesa hypotube (e.g., comprising stainless steel). In some embodiments, theproximal portion 200 comprises for example, platinum, titanium, nickel,chromium, cobalt, tantalum, tungsten, iron, manganese, molybdenum, andalloys thereof including nickel titanium (e.g., nitinol), nickeltitanium niobium, chromium cobalt, copper aluminum nickel, ironmanganese silicon, silver cadmium, gold cadmium, copper tin, copperzinc, copper zinc silicon, copper zinc aluminum, copper zinc tin, ironplatinum, manganese copper, platinum alloys, cobalt nickel aluminum,cobalt nickel gallium, nickel iron gallium, titanium palladium, nickelmanganese gallium, stainless steel, shape memory alloys, etc., polymerssuch as, for example, silicone, polyurethane (e.g., Polyslix, availablefrom Duke Extrusion of Santa Cruz, Calif.), polyethylene (e.g., Rexell®,available from Huntsman) including low density polyethylene (LDPE),linear low density polyethylene (LLDPE), medium density polyethylene(MDPE), and high density polyethylene (HDPE), fluoropolymers such asfluorinated ethylene propylene, PFA, MFA, PVDF, THV, ETFE, PCTFE, ECTFE(e.g., Teflon® FEP, available from DuPont), polypropylene, polyestersincluding polyethylene terephthalate (PET), PBT, PETG (e.g., Hytrel®,available from DuPont), PTFE, combination polymer compounds such asthermoplastic polyurethanes and polyether block amides (e.g., Propell™available from Foster Corporation of Putnam, Conn.), polyether blockamides (e.g. Pebax® available from Arkema of Colombes, France, PebaSlix,available from Duke Extrusion of Santa Cruz, Calif.), polyether softblocks coupled with polyester hard blocks vinyls such as PVC, PVDC,polyimides (e.g., polyimides available from MicroLumen of Oldsmar,Fla.), polyamides (e.g., Durethan, available from Bayer, Nylon 12,available from Duke Extrusion of Santa Cruz, Calif.), polycarbonate(e.g., Corethane™, available from Corvita Corp. of Miami, Fla.),styrenics such as PS, SAN, ABS, and HIPS, acetals such as copolymers orhomopolymers, PLA, PGA, PLGA, PCL, polyorthoesters, polyanhydrides, andcopolymers thereof, high temperature performance polymers such as PEEK,PES, PPS, PSU, LCP, combinations thereof, and the like.

In some embodiments, the tubular structure 202 has an outer diameterbetween about 0.35 mm and about 0.65 mm (e.g., between about 0.4 mm andabout 0.45 mm), between about 0.1 mm and about 0.5 mm (e.g., betweenabout 0.25 mm and about 0.33 mm (e.g., about 0.0125 inches (approx.0.318 mm))). In some embodiments, for example for use with peripheralvasculature, the tubular structure 202 has an outer diameter betweenabout 0.5 mm and about 10 mm. In some embodiments, the tubular structure202 has an inner diameter between about 0.2 mm and about 0.4 mm (e.g.,about 0.25 mm). In some embodiments, the tubular structure 202 has awall thickness t_(w), or difference between the outer diameter (OD) andthe inner diameter (ID) (OD−ID=t_(w)) between about 0.001 inches(approx. 0.025 mm) and about 0.02 inches (approx. 0.5 mm).

In some embodiments, the tubular structure 202 has a length betweenabout 2 feet (approx. 61 cm) and about 10 feet (approx. 305 cm) (e.g.,about 7 feet (approx. 213 cm)). In some embodiments, the tubularstructure 202 has a length between about 80 cm and about 210 cm, betweenabout 80 cm and about 120 cm, between about 120 cm and about 150 cm,between about 150 cm and about 210 cm (e.g., about 180 cm). The lengthof the proximal portion 200 may at least partially depend on a lengthdesired to reach somewhat proximate to a treatment site (e.g., proximalto the treatment site at least by the length of the distal portion 100).For example, a length between about 80 cm and about 120 cm may be usefulfor treating peripheral vasculature, a length between about 120 cm andabout 150 cm may be useful for treating coronary vasculature, and alength between about 180 cm and about 210 cm (e.g., about 180 cm) may beuseful for treating neurovasculature. In some embodiments, the tubularstructure 202 has a length greater than about 6 feet (approx. 183 cm).

At least some of the slits 204 include a first slit portion 204 a and asecond slit portion 204 b with struts or stems or anchor points 206between the first slit portion 204 a and the second slit portion 204 b.The struts 206 illustrated in FIGS. 12A and 12B are circumferentiallybetween about 175° and about 185° (e.g., about 180°) apart and act aspivot points or anchor points for the tubular structure 202. Othercircumferential spacing is also possible, for example to provide moreflexibility in one of the two degrees of freedom provided by that slit.

The slits 204 illustrated in FIGS. 12A and 12B are at an angle withrespect to the longitudinal axis of the tubular structure 202. In someembodiments, the angle is between about 95° and about 115° (e.g., theslits 204 are not transverse to the longitudinal axis). In someembodiments, the angle is about 90° (e.g., the slits are transverse tothe longitudinal axis).

In some embodiments, forming the slits 204 includes laser cutting thetubular structure 202. In certain such embodiments, the laser isprogrammed to cut all the way through a wall of the tubular structure202. The slit 204 may be thin enough that the laser can cut the entireslit 204 in one pass, or the slit 204 may be thick enough that the lasercreates an outline of the slit 204, which can remove the materialbetween the outline. Other methods of forming the slits 204 are alsopossible (e.g., mechanical cutting, lithographic patterning, etc.).

FIG. 14C is a schematic front elevational view of an example embodimentof a proximal portion 6605 of a vascular treatment device. As describedherein, certain features of a cut pattern can inhibit or avoid pinchpoints such that in some implementations the outer surface of thehypotube 6515 can remain uncovered. In some embodiments, the hypotube6515 can include an outer coating 6520 due to being coated (e.g.,dip-coated, spray coated, polymer extruded) with a polymer (e.g., to athickness between about 0.0001 inches and about 0.0002 inches (approx.between about 0.0025 mm and about 0.0051 mm)). In some embodiments, theinner walls of the hypotube 6515 can include a coating 6310 (e.g., ahydrophilic coating or a hydrophobic coating) due to being coated (e.g.,dip-coated, spray coated, polymer extruded) with a polymer (e.g., to athickness between about 0.0001 inches and about 0.0002 inches (approx.between about 0.0025 mm and about 0.0051 mm)). The inner coating 6510may be the same or different than the outer coating 6520. In someembodiments, a parameter of a coating (e.g., material, thickness,durometer, etc.) may be varied to vary flexibility of the catheter. Thecatheter may include a working lumen 6305. The variation may be insteadof or in addition to (e.g., complementary to) variation in the cutpattern in the hypotube 6515.

In some embodiments, a hypotube 6515 with a cut pattern as describedherein may be used as a catheter (e.g., a microcatheter, a distal accessmicrocatheter, a guide catheter) including an inner lumen 6505. In someembodiments, a hypotube 6515 with a cut pattern as described herein,with or without other layers such as an inner coating and/or an outercoating, may be used for a portion of a catheter or any other tubulardevice that might benefit from an advantage provided thereby. Forexample, the hypotube 6515 may be used as a pusher wire for a stentdeployment system. For another example, the hypotube 6515 may be used asan outer sheath for vascular treatment system. For further examples, thehypotube 6515 may be used as a tracheostomy tube, an endoscopy tube, acolonoscope, a laparoscope, a trans-esophageal echo (TEE) probe, aventriculostomy catheter, a chest tube, a central venous catheter, acooling catheter, etc.

FIG. 14D is a schematic side partial cross-sectional view of an exampleembodiment of a balloon catheter 6550. The balloon catheter 6550 may be,for example, a balloon guide catheter or a distal access microcatheterincluding a balloon. The balloon catheter 6550 can be used, for example,for angioplasty (e.g., plain old balloon angioplasty (POBA), drug-coatedballoon (DCB, DEB) angioplasty), atherectomy (e.g., if the balloon 6530comprises a cutting balloon, expansion of a endoprosthesis (e.g., stent,valve), temporary flow arrest during mechanical thrombectomy, thrombusaspiration, proximal embolic protection device, other devices, etc.

The balloon catheter 6550 comprises a hypotube 6515 and a balloon 6530.The hypotube 6515 includes a lumen 6505 configured to inflate and/ordeflate the balloon 6530. At least part of the length of the hypotube6515 includes a cut pattern 6525, for example the staggered and offsetinterspersed cut pattern as described herein, which can provide at leastone of flexibility, torquability, etc. as described herein to theballoon catheter 6530. The cut pattern may be angled or non-angled(e.g., as shown in FIG. 14D). Other variations of the cut patternsdescribed herein are also possible. In the embodiment illustrated inFIG. 14D, the part of the hypotube 6515 radially inward of the balloon6532 includes the cut pattern, and, for clarity in illustration, theparts of the hypotube 6515 proximal and distal to the balloon 6530 areillustrated without a cut pattern. Fluid (e.g., air, water, saline,etc.) used to inflate the balloon 6530 can traverse between the lumen6505 and the interior volume of the balloon 6535 through the kerfs 6540of the cut pattern. In some embodiments, the part of the hypotube 6515radially inward of the balloon 6532 includes a different cut pattern(e.g., configured to deliver fluid).

In the embodiment illustrated in FIG. 14D, the parts of the hypotube6515 proximal and/or distal to the balloon 6530 include the cut pattern(not shown), an outer coating 6520, and an inner coating 6510. Forexample, parts proximal to the balloon 6528 may include the cut patternand parts distal to the balloon 6536 may not include the cut pattern.The inner coating 6510 and/or the outer coating 6520 occlude the kerfs6540, which can allow the fluid to flow through the lumen 6505 to thepart including the balloon 6530. FIG. 14C may be a cross-section of theballoon catheter 6550 across the line 14C-14C in FIG. 14D, which is at apoint along the hypotube 6515 that does not include kerfs. In someembodiments, the hypotube 6515 includes only one of the inner coating6510 and the outer coating 6520. In some embodiments, different parts ofthe hypotube 6515 proximal and distal to the balloon 6530 comprise oneor both of the inner coating 6510 and the outer coating 6520. In someembodiments, parts of the hypotube 6515 do not include the inner coating6510 or the outer coating 6520, but the kerfs 6540 are occluded by apolymer. For example, the polymer may be flush with the inner and/orouter surfaces of the hypotube 6515. In embodiments in which the balloon6530 is at the distal end of the hypotube 6515, the parts of thehypotube 6515 distal to the balloon 6536 are short, do not exist, and/ordo not include the cut pattern. In certain such embodiments, parts ofthe hypotube 6515 distal to the balloon 6536 do not include the cutpattern, the outer coating 6520, and/or the inner coating 6510. In someembodiments, parts of the hypotube 6515 without the cut pattern do notinclude the inner coating 6510 or the outer coating 6520, for examplebecause those parts do not include kerfs 6540. The distal end of thehypotube 6515 may be occluded, for example by a polymer, solder,crimping, a plug, combinations thereof, and the like. In someembodiments, the distal end of the balloon catheter 6536 comprises anatraumatic polymer tip 6538 including a tapered inner diameter. Incertain such embodiments, a second catheter (e.g., a distal accesscatheter or a microcatheter) and/or a third catheter (e.g., a distalaccess catheter or a microcatheter) may be inserted through a workinglumen created by the hypotube 6515. The outer diameter (e.g., 6 Fr) ofthe second catheter and/or the third catheter is substantially similarto or at least as large as the inner diameter (e.g., 6 Fr) of thepolymer tip, which can create an arcuate seal of the working lumen,which can allow inflation of the balloon 6530 without permanentocclusion. A proximal segment of the hypotube 6515 where torque appliedby an operator of the balloon catheter 6550 is the greatest may beconfigured to reduce kinking, for example comprising a strain relief(e.g., polymer sheath that may be the same as or different to the outercoating 6520), a braided structure, combinations thereof, and the like.

The hypotube 6515 can comprise hypotube materials, dimensions, etc.described herein. Portions of the balloon catheter 6550 (e.g., theballoon 6530, the inner coating 6510, the outer coating 6520) maycomprise a biomedical polymer, for example, silicone, polyurethane(e.g., Polyslix, available from Duke Extrusion of Santa Cruz, Calif.),polyethylene (e.g., Rexell®, available from Huntsman) including lowdensity polyethylene (LDPE), linear low density polyethylene (LLDPE),medium density polyethylene (MDPE), and high density polyethylene(HDPE), fluoropolymers such as fluorinated ethylene propylene, PFA, MFA,PVDF, THV, ETFE, PCTFE, ECTFE (e.g., Teflon® FEP, available fromDuPont), polypropylene, polyesters including polyethylene terephthalate(PET), PBT, PETG (e.g., Hytrel®, available from DuPont), PTFE,combination polymer compounds such as thermoplastic polyurethanes andpolyether block amides (e.g., Propell™ available from Foster Corporationof Putnam, Conn.), polyether block amides (e.g. Pebax® available fromArkema of Colombes, France, PebaSlix, available from Duke Extrusion ofSanta Cruz, Calif.), polyether soft blocks coupled with polyester hardblocks vinyls such as PVC, PVDC, polyimides (e.g., polyimides availablefrom MicroLumen of Oldsmar, Fla.), polyamides (e.g., Durethan, availablefrom Bayer, Nylon 12, available from Duke Extrusion of Santa Cruz,Calif.), polycarbonate (e.g., Corethane™, available from Corvita Corp.of Miami, Fla.), styrenics such as PS, SAN, ABS, and HIPS, acetals suchas copolymers or homopolymers, PLA, PGA, PLGA, PCL, polyorthoesters,polyanhydrides, and copolymers thereof, high temperature performancepolymers such as PEEK, PES, PPS, PSU, LCP, combinations thereof, and thelike. In some embodiments, the balloon catheter 6550 comprisesradiopaque markers 6542, 6548, proximate to the proximal and distal endsof the balloon 6530. For example, as illustrated in FIG. 14D, theradiopaque markers 6542, 6544, 6546, 6548, comprise filled in kerfs(e.g., as described in further detail with respect to FIG. 19B). In theembodiment illustrated in FIG. 14D, the balloon catheter 6530 comprisesa plurality of radiopaque markers 6549 at regular intervals, which mayhelp to measure clot length, degree or length of a stenosis in a vessel,diameter of a vessel, dimensions of an aneurysm arising from a vessel(e.g., the mouth of the aneurysm), etc. for intra-operative decisionmaking on device selection.

FIG. 15A is a schematic diagram illustrating an example embodiment of acut pattern. The pattern includes two interspersed patterns: Pattern A,indicated by the shaded blocks, and Pattern B, indicated by the unshadedblocks. FIG. 15B is a schematic diagram illustrating an exampleembodiment of a portion of a cut pattern, Pattern A illustrated in FIG.15A without Pattern B. FIG. 15C is a schematic diagram illustratinganother example embodiment of a portion of a cut pattern, Pattern Billustrated in FIG. 15A without Pattern A.

Pattern A includes a series of arcuate slits 210 (including the slithalves 210 a, 210 b), 212 (including the slit halves 212 a, 212 b), 214(including the slit halves 214 a, 214 b), 216 (including the slit halves216 a, 216 b), etc. Pattern B includes a series of arcuate slits 220(including the slit halves 220 a, 220 b), 222 (including the slit halves222 a, 222 b), 224 (including the slit halves 224 a, 224 b), 226(including the slit halves 226 a, 226 b), 228 (including the slit halves228 a, 228 b), etc. The slits 210, 220, et al. are not fully arcuate)(360°, which would cut the tubular structure 202 in two pieces, but areinterrupted by two stems or struts or anchor points (e.g., the stems 221a, 221 b between the slit halves 220 a, 220 b, the stems 211 a, 211 bbetween the slit halves 210 a, 210 b) circumferentially spaced about180° apart by the two halves of an arcuate slit. When the slits 210 areperpendicular to the longitudinal axis, a row is defined by slit halves210 a, 210 b around that circumference. When the slits 210 are angledother than perpendicular to the longitudinal axis, a row is defined byslit halves 210 a, 210 b and stems 211 a, 211 b therebetween that havetraversed a full circumference of the tubular structure 202.

The arrows 310 indicate that the view is exploded outward, or that ifthis is a laser cut sheet that is rolled into a tube by bending the leftand right sides into the page such that the pattern shown is for anouter circumference. The inside of the tubular structure 202 has acircumference c_(i)=ρd_(h), where d_(h) is the inner diameter of thetubular structure 202. The outside of the tubular structure 202 has acircumference c_(o)=πd_(o), where d_(o) is the outer diameter of thetubular structure 202. A ratio of the circumferential length of a slit204 to the circumference c_(o) can be calculated. Parameters of theslits 204 can be represented as absolute values (e.g., in inches or mm)or as a percentage of c_(i) or c_(o). Once the ratio between c_(i) andc_(o) is known, values related to the proximal portion 200 that areknown for c_(o) (e.g., as may be provided to a manufacturer) may becalculated and/or derived therefrom with reference to c_(i), and viceversa.

In some embodiments, the slit 210, for example, includes one slit andone stem. In some embodiments, the slit 210 includes two slit portions210 a, 210 b (e.g., for example as described in detail herein). In someembodiments, the slit 210 includes four slit portions (e.g., with stemsspaced about 90° apart). Other numbers of slit portions and stems arealso possible.

Anchor points that are substantially diametrically opposed along acircumference of the tubular structure 202 (e.g., two anchor points 211a, 211 b spaced about 180° apart) can allow a freedom of flexibilityabout the anchor points. Anchor points that are not substantiallydiametrically opposed are also possible, which can create uneven freedomof movement about the anchor points to create a higher degree of freedomof flexibility in one direction and a lower degree of freedom offlexibility in the opposite direction. The anchor points can inhibit orprevent compression of the proximal portion 200 in the direction inwhich they extend, but can support freedom of movement in a direction90° away from the location of the anchor points, the direction offreedom.

In some embodiments, longitudinally adjacent stems are generally notlongitudinally aligned (parallel along the longitudinal axis of thetubular structure 202), which could result in pinching at any pointalong the proximal portion 200, similar to the pinching that may becaused by a continuous coil or spiral cut. Rather, stems in adjacentrows of Pattern A are offset by a circumferential distance O_(A) (FIG.15B) and stems in adjacent rows of Pattern B are offset in the oppositedirection by a circumferential distance O_(B) (FIG. 15C). Stems inadjacent rows of the overall cut pattern are staggered by acircumferential distance S. Staggering and/or offsetting thecircumferential positioning of the stems can increase the number ofdegrees of motion and/or increase safety by reducing or eliminating thepossibility of pinching. In embodiments comprising two patterns (e.g.,Patterns A and B), both patterns can be offset in a clockwise direction,both patterns can be offset in a counterclockwise direction, or onepattern can be offset in a clockwise direction and the other pattern canprogress in a counterclockwise direction (e.g., as illustrated in FIG.15A).

In some embodiments, the value of the offset O_(A) (and O_(B)) isproportional to the circumferential length 230 of the slit half betweenthe stems, also called the kerf length. The ratio of the offset to thecircumferential length of the slit half may determine how quickly thestems are aligned longitudinally or, colloquially, how quickly aparticular slit or row repeats itself along the tubular structure 202.For example, if the ratio is ⅛, then the first, ninth, seventeenth, etc.slits would be the same, the second, tenth, eighteenth, etc. slits wouldbe the same, and so on. In some embodiments, a row of a pattern mayrepeat between about every 2 rows and about every 20 rows. Higherrepetition may be desired, but may be limited by geometry, manufacturingtolerances, etc.

Referring again to FIG. 15A, the stems 211 a, 211 b in Pattern A and thestems 221 a, 221 b in Pattern B do not start out aligned and arestaggered by a value S. In some embodiments, the stems 211 a, 211 b inPattern A and the stems 221 a, 221 b in Pattern B are never alignedalong the length of the tubular structure 202. In some embodiments, thestagger S between the stems 211 a, 211 b in the first row of Pattern Aand the stems 221 a, 221 b in the first row of Pattern B can helpinhibit alignment of the stems of Patterns A and B if related to thelength 230 of the slit halves. For example, an initial stagger S that isabout 40% of the length of the slit halves can reduce or minimize theincidence of longitudinally adjacent stems of Patterns A and B beinglongitudinally aligned.

FIG. 15D is a schematic diagram illustrating an example embodiment ofstaggered interspersed cut patterns. Patterns A and B are interspersed.The right end of the slit 210 a of Pattern A is staggered from the rightend of the slit 220 a of Pattern B by a value S. The right end of theslit 210 a of Pattern A is also offset from the right end of the slit212 a of Pattern A by a value O_(A). The left end of the slit 220 a ofPattern B is offset from the left end of the slit 222 a of Pattern B bya value O_(B). In some embodiments, the number of cut patterns that areinterspersed is between 1 (e.g., the same cut pattern without anyinterspersing) and 5 (e.g., 2 as described in detail herein). A proximalportion 200 including two interspersed patterns can increase the numberof degrees of freedom of rotation or movement, which can help withnavigation through narrow vessels. The interspersing can be the entirelength of the proximal portion 200 or sections thereof. In someembodiments, two cut patterns are interspersed for a first length of theproximal portion 200 and two cut patterns (one or both of which may bedifferent than the two cut patterns along the first length) for a secondlength of the proximal portion 200, etc.

FIG. 15E is a schematic diagram illustrating an example embodiment ofstaggered interspersed offset cut patterns. The left and right sides ofFIG. 15E show the same cuts, but shaded differently to highlight thevarious cut patterns. On the left side, Pattern A is shown in dashedoutline without shading and Pattern B is shown in solid outline and withshading. The right end of the slit 210 a is offset from the right end ofthe slit 212 a by a value of O_(A). The right end of the slit 212 a isoffset from the right end of the slit 214 a by a value of O_(A). Theright end of the slit 214 a is offset from the right end of the slit 216a by a value of O_(A). The right end of the slit 210 a is offset fromthe right end of the slit 214 a by a value of 2×O_(A). The right end ofthe slit 210 a is offset from the right end of the slit 216 a by a valueof 3×O_(A). The offset O_(A) is to the right, as indicated by the arrow242.

On the right side, Pattern B is shown in dashed outline without shadingand Pattern A is shown in solid outline and with shading. The left endof the slit 220 a is offset from the left end of the slit 222 a by avalue of O_(B). The left end of the slit 222 a is offset from the leftend of the slit 224 a by a value of O_(B). The left end of the slit 224a is offset from the left end of the slit 226 a by a value of O_(B). Theleft end of the slit 226 a is offset from the left end of the slit 228 aby a value of O_(B). The left end of the slit 220 a is offset from theleft end of the slit 224 a by a value of 2×O_(B). The left end of theslit 220 a is offset from the left end of the slit 226 a by a value of3×O_(B). The left end of the slit 220 a is offset from the left end ofthe slit 228 a by a value of 4×O_(B). The offset O_(B) is to the left,as indicated by the arrow 244. The offset O_(B) may be considerednegative in comparison to the offset O_(A) because it is in the oppositedirection.

The offset O_(A) is different than the offset O_(B), which may be easilyseen by the different slopes of the lines 242, 244, or the intra-patternanchor point stagger angle. Referring also again to FIG. 15D, the offsetO_(A), offset O_(B), and stagger S may at least partially influence therepetition a single row or frequency of rows having longitudinallyaligned stems.

Although some patterns illustrated herein are interspersed by havingalternating slits of a first pattern and a second pattern (e.g., PatternA slit, Pattern B slit, Pattern A slit, Pattern B slit, etc.), slitpatterns may be interspersed in other ways. For example, two slits fromeach of two patterns may alternate (e.g., Pattern A slit, Pattern Aslit, Pattern B slit, Pattern B slit, Pattern A slit, Pattern A slit,Pattern B slit, Pattern B slit, etc.). For another example, one slit ofa first pattern may alternate with two slits of a second pattern (e.g.,Pattern A slit, Pattern B slit, Pattern B slit, Pattern A slit, PatternB slit, Pattern B slit, etc.). For yet another example, slits from threeor more patterns may be interspersed (e.g., Pattern A slit, Pattern Bslit, Pattern C slit, Pattern A slit, etc.).

In some embodiments, the proximal portion 200 includes a plurality oflongitudinally-spaced slits 204 including a first slit 220, a secondslit 210, a third slit 222, and a fourth slit 212. The slit 220 includesa first slit half 220 a and a second slit half 220 b. A first stem 221 ais between the first slit half 220 a and the second slit half 220 b, anda second stem 221 b is between the first slit half 220 a and the secondslit half 220 b and about circumferentially about 180° from the firststem 221 b. The slit 210 includes a first slit half 210 a and a secondslit half 210 b. A first stem 211 a is between the first slit half 210 aand the second slit half 210 b, and a second stem 211 b is between thefirst slit half 210 a and the second slit half 210 b and aboutcircumferentially about 180° from the first stem 211 b. The slit 222includes a first slit half 222 a and a second slit half 222 b. A firststem 223 a is between the first slit half 222 a and the second slit half222 b, and a second stem 223 b is between the first slit half 222 a andthe second slit half 222 b and about circumferentially about 180° fromthe first stem 223 b. The slit 212 includes a first slit half 212 a anda second slit half 212 b. A first stem 213 a is between the first slithalf 212 a and the second slit half 212 b, and a second stem 213 b isbetween the first slit half 212 a and the second slit half 212 b andabout circumferentially about 180° from the first stem 221 b. The stems221 a, 221 b are each circumferentially offset from the stems 211 a, 211b, the stems 223 a, 223 b, and the stems 213 a, 213 b. The stems 211 a,211 b are each circumferentially offset from the stems 221 a, 221 b, thestems 223 a, 223 b, and the stems 213 a, 213 b. The stems 223 a, 223 bare each circumferentially offset from the stems 221 a, 221 b, the stems211 a, 211 b, and the stems 213 a, 213 b. The stems 213 a, 213 b areeach circumferentially offset from the stems 221 a, 221 bm the stems 211a, 211 b, and the stems 223 a, 223 b. Within a three ring window or afour ring window, none of the stems are circumferentially aligned. Otherlarger windows without circumferential stem alignment are also possible(e.g., between about 3 rings and about 100 rings, between about 3 ringsand about 50 rings, between about 3 rings and about 25 rings), forexample depending on offset and stagger values.

FIG. 16A is a schematic diagram illustrating an example embodiment of anangled pattern including sharp edges. The pattern is angled from theorthogonal, indicated by the dashed line, by the angle 250. The angle250 may be between about 5° and about 25°. The angle 250 may be betweenabout −5° and about −25° (e.g., angled in the opposite direction). Thepattern(s) include slits having sharp edges, for example ends with 90°corners. Other sharp ends are also possible (e.g., trapezoidal slitswith corners more or less than 90°). Sharp edges may provide greaterslit end robustness, but may produce cilia, or minute hair-likefollicles of material, that can result from rerouting a cutter (e.g., alaser cutter) at sharp corners. Cilia can be removed by a process likeelectropolishing, but that can increase cost and risk unremoved cilia,which could be fatal if herniated into vasculature.

FIG. 16B is a schematic diagram illustrating an example embodiment of anangled pattern including rounded edges. The pattern is angled from theorthogonal, indicated by the dashed line, by the angle 250. The angle250 may be between about 5° and about 25°. The angle 250 may be betweenabout −5° and about −25° (e.g., angled in the opposite direction). Thepattern(s) include slits having rounded edges, for example arcuate orrounded (e.g., semicircular, rounded corners) ends. Rounded slits mayreduce or eliminate the incidence of cilia. Reduced or eliminated ciliacan eliminate cilia-removal processes, reducing manufacturing costs.Reduced or eliminated cilia can increase safety of the device byreducing or eliminating the chances of a cilium herniating intovasculature. Rounded slits may reduce or minimize fracture points.

FIG. 16C is a schematic diagram illustrating an example embodiment ofinterspersed offset horizontal patterns including sharp edges. The leftand right sides of FIG. 16C show the same cuts, but shaded differentlyto highlight the various cut patterns. Similar to FIG. 15E, described indetail above, the left side of FIG. 16C shows an arrow 242 connectingthe right sides of a first pattern including a first offset and theright side of FIG. 16C shows an arrow 244 connecting the left sides of asecond pattern including a second offset, the first pattern and thesecond pattern interspersed with and staggered from each other. Thepatterns in FIG. 16C are shown horizontal, but could be angled, forexample as illustrated in FIG. 16A.

FIG. 16D is a schematic diagram illustrating an example embodiment ofinterspersed offset horizontal patterns including rounded edges. Theleft and right sides of FIG. 16D show the same cuts, but shadeddifferently to highlight the various cut patterns. Similar to FIG. 15E,described in detail above, the left side of FIG. 16D shows an arrow 242connecting the right sides of a first pattern including a first offsetand the right side of FIG. 16D shows an arrow 244 connecting the leftsides of a second pattern including a second offset, the first patternand the second pattern interspersed with and staggered from each other.The patterns in FIG. 16D are shown horizontal, but could be angled, forexample as illustrated in FIG. 16C.

FIG. 16E is a schematic diagram illustrating an example embodiment ofslits and stems along the length of an example embodiment of a proximalportion 270. Above the dashed line, one of two stems of a first patternin a numbered slit row is shaded for easier visualization of therepetition of the row. The shaded stem or anchor point in row 1 is thesame as the shaded stem or anchor point in row 11, showing that thestems repeat every 10th row. As described above, the ratio of the offsetto the circumferential length of the slit half may determine how quicklythe stems are aligned longitudinally or, colloquially, how quickly aparticular slit repeats itself along the tubular member. For example, inthe example illustrated in the top half of FIG. 16E, such a ratio may be1/10 so that the first, eleventh, etc. slits and stems would be thesame, the second, twelfth, etc. slits and stems would be the same, andso on. The pattern for which the stems are shaded is interspersed with asecond pattern so that the actual repetition rate is about half of theratio. For example, nine rows of the second pattern are between thefirst and eleventh row of the first pattern, so there are actuallynineteen rows of slits and stems before the repetition of a row.

Below the dashed line in FIG. 16E, one of two stems of a second patternin a numbered slit row is shaded for easier visualization of therepetition of the row. The shaded stem in row 1 is the same as theshaded stem in row 11, showing that the stems repeat every 10th row. Asdescribed above, the ratio of the offset to the circumferential lengthof the slit half may determine how quickly the stems are alignedlongitudinally or, colloquially, how quickly a particular slit repeatsitself along the tubular member. For example, in the example illustratedin the bottom half of FIG. 16E, such a ratio may be 1/10 so that thefirst, eleventh, etc. slits and stems would be the same, the second,twelfth, etc. slits and stems would be the same, and so on. The patternfor which the stems are shaded is interspersed with the first pattern sothat the actual repetition rate is about half of the ratio. For example,nine rows of the first pattern are between the first and eleventh row ofthe second pattern, so there are actually nineteen rows of slits andstems before the repetition of a row.

FIG. 16F is a schematic diagram illustrating another example embodimentof slits and stems along the length of an example embodiment of aproximal portion 272. One of two stems of each of two interspersed andstaggered offset patterns is shaded for easier visualization of thepattern. Arrows are also provided connecting similar points of thepatterns for easier visualization of the pattern. In the section of theproximal portion 272 illustrated in FIG. 16F, neither of the patternsrepeats, and the patterns do not have any rows that match. The sectionof the proximal portion 272, which has twenty rows, has twenty degreesof freedom of movement, one at each row. In contrast, slotted hypotubesin which stems are offset by 90° every row such that every other rowmatches have only two degrees of freedom along the entire length of thehypotube. Fewer degrees of freedom generally causes less flexibilityand/or maneuverability.

The flexibility of the proximal portion 200 can vary along at least asection of the length of the proximal portion 200, for example byvarying one or more parameter (e.g., angle of cut relative tolongitudinal axis, slit width, pitch or spacing between slits, ratio ofslit width to pitch, stem offset, ratio of stem offset to slit halflength, pattern stagger, etc.). The variation can be in discretelongitudinal segments, gradual, or combinations thereof. Gradualtransition between parameters, for example pitch, can inhibit or avoidkink points.

FIG. 17A is a schematic diagram illustrating an example embodiment of alaser cutting system 10100. The laser cutting system 10100 may includecustomized components that can be used to laser cut the interspersedpatterns of rows of kerfs in thin-walled tubes over relatively longlengths to form the proximal portions 200 of device 10, 20, or 40, forexample compared to stents are only few inches long at most. The lasercutting system 10100 comprises a cooling system 10105 configured to coolthe laser excitation source 10110 and/or the laser media or lasergenerating medium 10120.

In some embodiments, the laser cutting system 10100 includes a yttriumaluminum garnet (Y₃Al₅O₁₂, YAG) laser excitation source 10110, forexample instead of a carbon dioxide (CO₂) laser source for laser cuttinga proximal portion 200. The YAG laser utilizes infrared wavelength inthe 1.064 μm wavelength for laser cutting compared to a CO₂ laser thatutilizes infrared wavelength in the 10.64 μm wavelength for lasercutting. Compared to a CO₂ laser, the beam from the YAG laser has awavelength that is ten times smaller for laser cutting complexinterspersed smaller patterns and can create smaller heat impact puddlesand heat affected zones, which can reduce the risk of fissures orfractures in the stems of the laser cut hypotubes. The heat impactpuddle is the initial point of contact of the laser beam on the hypotubeduring the laser cutting process. The heat affected zone is the area ofthe base material of the hypotube surrounding the initial point ofcontact of the laser beam, which can have its microstructure andproperties altered because of heat intensive laser cutting operations ofthe laser beam.

In some embodiments, a relatively smaller heat impact puddle and heatimpact zone can be achieved by utilizing an infrared wavelength betweenabout 1.060 μm and about 1.070 μm, which can generate a smaller laserbeam, which can reduce the risk of fissures or fractures during lasercutting small patterns on the proximal portion 200. In some embodiments,a ytterbium (Yb³⁺) doped YAG laser or a neodymium (Nd³⁺) doped YAG lasercan help generate infrared wavelengths between about 1.060 μm and about1.070 μm, for example compared to an erbium (Er³±) doped YAG laser.

The laser cutting system 10100 illustrated in FIG. 17A comprises a laserexcitation source 10110 that can help excite the ions in the lasermedium or crystal in the laser medium or laser generating medium 10120.Excitation of the Yb³⁺ or Nd³⁺ ions by the laser excitation source 10110can result in specific energy level transitions for the Yb³⁺ or Nd³⁺ions, and the resulting energy level transitions from a higher or upperenergy level to a lower energy level can create specific infraredwavelengths between about 1.060 μm and about 1.070 μm, which cangenerate a relatively smaller laser beam with relatively smaller heatimpact puddles and heat affected zones.

In some embodiments in which the laser cutting system 10100 includes alaser medium 10120 that is ytterbium-doped yttrium aluminum garnet(Yb:Y₃Al₅O₁₂), the laser excitation source 10110 can excite the Yb³⁺ions, which can result in ytterbium ion energy level transitions fromthe upper energy level or the upper Stark level manifold ²F_(5/2) to thelower energy level or lower Stark level manifold ²F_(7/2), which cangenerate a wavelength of about 1.060 μm in the infrared wavelengthrange, which can generate relatively smaller heat impact puddles andheat affected zones.

In some embodiments in which the laser cutting system 10100 includes alaser medium 10120 that is neodymium-doped yttrium aluminum garnet(Nd:Y₃Al₅O₁₂), the laser excitation source 10110 can excite the Nd³⁺ions, which can result in neodymium ion energy level transitions fromthe upper energy level or the upper Stark level manifold ⁴F₃₁₂ to thelower energy level or lower Stark level manifold ⁴I_(11/2), which cangenerate a wavelength of about 1.060 μm in the infrared wavelengthrange, which can generate relatively smaller heat impact puddles andheat affected zones.

Referring again to FIG. 17A, the infrared wavelength laser beam that isgenerated by exciting the ions of the laser medium 10120 may bereflected across a plurality of mirrors and lenses, for example a rearmirror 10115 and a front minor 10125. In some embodiments, theconcentrated laser beam can be focused onto the hypotube of the proximalportion 200 via a lens 10145.

Heat may be generated during the process of the laser beam impacting thehypotube of the proximal portion 200. In some embodiments, an externalgas (e.g., air) based cooling system 10130 for the laser beam can reducethe heat impact puddle and the heat affected zone, and may help removeexternal slag 10155 generated during the laser cutting process, whichmay be collected in an external slag collecting device 10150. Theexternal gas cooling system 10130 includes a supply of gas that can flowinto a laser nozzle in the direction indicated by the 10140. An externalgas inflow valve 10135 can regulate the gas that circulates into thelaser nozzle to reduce the heat impact puddle and the heat impact zone.

In some embodiments, the hypotube of the proximal portion 200 that isbeing laser cut may be carefully handled to reduce the chance of kinkingor fracturing the hypotube 200. The laser cutting system 10100 includesa hypotube collector device 10200 including a spiral collectorconfigured to wind the hypotube of the proximal portion 200 after lasercutting, which can inhibit kinking or otherwise damaging the laser-cuthypotube 200. The external gas cooling system 10130 can provide coolingto the hypotube collector device 10200. The external gas cooling system10130 includes a supply of gas that can flow into the hypotube collectordevice 10200. An external gas inflow valve 10205 can regulate the gasthat circulates into the hypotube collector device 10200, which can coolthe laser-cut hypotube 200 and reducing the heat affected zone. The gasused for the external cooling system 10130 can include, for example,ambient air or inert gas. In some embodiments, the temperature of thegas is at about ambient temperature (e.g., between about 20° C. andabout 25° C.) and the external gas cooling is continued for all or aportion of the duration of the laser cutting process.

In the laser cutting system 10100 illustrated in FIG. 17A, the hypotubeof the proximal portion 200 is held in position by a bushing 10160configured to inhibit motion of the hypotube 200 prior to the laser beamimpacting the hypotube 200, one or more collets 10165 configured toreduce sag of the relatively long hypotube 200 and/or to maintainadequate tension F_(t) on the hypotube 200 as the hypotube 200 is beingadvanced towards the laser beam, and a hypotube clamp that is part of amotor 10175 and hypotube dispenser 10180 that hold the hypotube 200 andhelp advance the hypotube 200 forward towards the laser beam.

In some embodiments, the system 10100 includes an external water inletregulator device 10190 including a pressure valve 10197 configured topump water through a series of water injection tubes 10195 and aconstrictive water inlet gate 10187 configured to inject water into theinner lumen of the hypotube 200. The external water inlet regulatordevice 10190 injects water into the hypotube 200 at a certain velocity,which can assist with removal of the slag 10155 that is generated duringthe laser cutting process by removing the slag 10155 before the slag10155 has time to sediment and adhere to the inner lumen of the hypotube200. The external water inlet regulator device 10190 can assist withcooling the hypotube 200 during the laser cutting process and reduce thesize of the heat impact puddle and/or the size of the heat affectedzone. The laser cutting system 10100 may include a laser controller box10170 configured to controls one, some, or all the processes withinlaser cutting system 10100 (e.g., shown in communication with the waterinlet regulator device 10190.

In some embodiments, a proximal portion 200 comprises a hypotubeincluding the Patterns A and B described herein with a variable pitchbetween slits, which increases flexibility from proximal to distal. ThePatterns A and B may be formed, for example, by laser cutting using, forexample, the system 10100. Each slit has a width along the longitudinalaxis (which may take into account an angle of the kerf) of about 0.001inches (approx. 0.025 mm). The longitudinal slit widths may have atolerance of ±0.0002 inches (approx. 0.005 mm). Longitudinally thickerand thinner slits are also possible. For example, a thicker slit mayprovide flexibility for thicker hypotubes. For another example, athinner slit may provide strength for thinner hypotubes. The kerf widthmay be greater than the width of a laser beam used to cut the kerf,which can inhibit formation of a heat impact puddle on an edge of thekerf because the initial heat impact puddle can be in a middle of thekerf and removed upon finishing cutting the kerf. The hypotube may havean outer diameter of about 0.0125 inches (approx. 0.318 mm) and an innerdiameter between about 0.001 inches (approx. 0.025 mm) and about 0.0011inches (approx. 0.028 mm).

In some embodiments, a ratio of a width of a kerf along a longitudinalaxis and a circumferential width of a strut at least partially definedby the kerf is between about 1:1 and about 2:1. For example, the kerfwidth may be about 0.003 inches (approx. 0.076 mm) and the strut widthmay be about 0.003 inches (approx. 0.076 mm) such that the ratio is 1:1.

FIG. 17B is a schematic diagram illustrating an example embodiment of acut design of a slit 6400. A heat impact puddle 6405 is the initialpoint of contact of the laser beam on the hypotube during the process ofcutting the kerf 6400 with the laser. The path of the laser beam is astraight line 6415 and the heat impact puddle 6405 is formed at the edgeof the kerf 6400. The heat affected zone is the area in which themicrostructure and/or properties of the base material of the hypotube isaltered by the laser beam. The diameter 6410 of the heat impact puddle6405 is larger than the width 6420 of the kerf 6400 such that the heataffected zone around the heat impact puddle 6405 remains part of the cutpattern, which can make the struts between the kerfs more prone tofractures or fissures 6430. The circumferential length 6440 of the kerf6400 is larger than the intended circumferential length of the kerf 6400due to the heat impact puddle 6405 being on the edge of the kerf 6400.

In some embodiments, the diameter 6410 of the heat impact puddle 6405can be larger than a width 6420 of the kerf 6400 without damaging thestructural integrity of the struts proximate to the heat impact puddle6405. Certain patterns described herein include struts and slits thatare close to each other along with the complexity of the interspersedlaser cut patterns in a thin-walled hypotube over the relatively longlength of the proximal portion 200 compared to, for example, laser-cutstents, and fractures and fissures may be inhibited or prevented if thelaser intensity and the laser beam angle are set such that the diameterof the heat impact puddle 6405 does not exceed about 120% of the width6420 of the kerf 6400. FIG. 17C is a schematic diagram illustrating anexample embodiment of an interspersed offset horizontal pattern 6500including slits 6400 and heat impact puddles 6405. FIG. 17C shows thepossible proximity of the kerfs 6400 with heat impact puddles 6405 andfractures 6430.

FIG. 17D is a schematic diagram illustrating another example embodimentof a cut design of a slit 6600. In some embodiments, the width 6420 andlength 6435 of the kerf 6600 may be greater than the width of a laserbeam used to cut the kerf 6600, which can inhibit formation of a heatimpact puddle on an edge of the kerf 6600. In the embodiment illustratedin FIG. 17D, the path 6415 of the laser beam starts with the heat impactpuddle 6405 in a central or intermediate or middle of the kerf 6600 andtravels up to an edge of the kerf 6600 and then along the edges of thekerf 6600, surrounding the heat impact puddle 6405, such that the heatimpact puddle and the heat affected zone can be removed or substantiallyremoved by the cutting process. In certain such embodiments, the removalof the heat impact puddle 6405 and the heat affected zone can maintainthe structural integrity of the struts and/or inhibit or preventformation of fractures or fissures.

FIG. 17E is a schematic diagram illustrating yet another exampleembodiment of a cut design of a slit 6700. In some embodiments, thewidth 6420 and length 6435 of the kerf 6700 may be greater than thewidth of a laser beam used to cut the kerf 6700, which can allow theheat impact puddle 3405 to be within the edges of the slit 6700. In theembodiment illustrated in FIG. 17E, the path 6415 of the laser beamstarts with the heat impact puddle 6405 in a central or intermediate ormiddle of the kerf 6700 and travels diagonally to the upper left cornerof the kerf 6700 and then along the edges of the kerf 6700, surroundingthe heat impact puddle 6405, such that the heat impact puddle and theheat affected zone can be removed or substantially removed by thecutting process. In certain such embodiments, the removal of the heatimpact puddle 6405 and the heat affected zone can maintains thestructural integrity of the struts and/or inhibit or prevent theformation of fractures or fissures.

FIG. 17F is a schematic diagram illustrating still another exampleembodiment of a cut design of a slit 6800. In some embodiments, thewidth 6420 and length 6435 of the kerf 6800 may be greater than thewidth of a laser beam used to cut the kerf 6800, which can allow theheat impact puddle 6405 to be within the edges of the slit 6800. In theembodiment illustrated in FIG. 17F, the path 6415 of the laser beamstarts with the heat impact puddle 6405 near the bottom right corner ofthe kerf 6800 but also within the edges of the slit 6800 and travelsdiagonally to the upper left corner of the kerf 6800 and then along theedges of the kerf 6800, surrounding the heat impact puddle 6405, suchthat the heat impact puddle and the heat affected zone can be removed orsubstantially removed by the cutting process. In certain suchembodiments, the removal of the heat impact puddle 6405 and the heataffected zone can maintains the structural integrity of the strutsand/or inhibit or prevent the formation of fractures or fissures.

FIG. 17G is a schematic diagram illustrating still yet another exampleembodiment of a cut design of a slit 7200. In some embodiments, thewidth 6420 and length 6435 of the kerf 7200 may be greater than thewidth of a laser beam used to cut the kerf 7200, which can allow theheat impact puddle 6405 to be within the edges of the slit 7200. In theembodiment illustrated in FIG. 17F, the path 6415 of the laser beamstarts with the heat impact puddle 6405 near the bottom left corner ofthe kerf 7200 but also within the edges of the slit 7200 and travels inan overlapping spiral pattern within the edges of the kerf 7200 and thenalong the edges of the kerf 7200, surrounding the heat impact puddle6405, such that the heat impact puddle and the heat affected zone can beremoved or substantially removed by the cutting process. In certain suchembodiments, the removal of the heat impact puddle 6405 and the heataffected zone can maintains the structural integrity of the strutsand/or inhibit or prevent the formation of fractures or fissures.

FIG. 17H is a schematic side elevational view of an example embodimentof a bushing 7300. FIG. 17I is a schematic cross-sectional frontelevational view of the bushing 7300 of FIG. 17H along the line 171-171.The bushing 7300 can the used to assist fixation of a hypotube 7315 toinhibit movement of the hypotube 7315 during a laser cutting process.The hypotube 7315 may be cut to be, for example, the proximal portion200 of the device 10, 20, 30, or 40. In some embodiments, the bushing7300 includes a proximal end 7314 through which an uncut hypotube 7315may be inserted, a middle segment 7310 within which the hypotube 7315 isstabilized, and a distal end 7304 through which the hypotube 7315emerges to be cut by the laser (e.g., as shown by the slits 7305 in thehypotube 7315 distal to the distal end 7304). As illustrated in FIG.17I, the bushing 7300 includes a cylindrical hole or aperture 7410within the middle segment of the bushing 7310 through which the hypotube7315 traverses. In some embodiments, the aperture 7410 has an innerdiameter of at least about 0.001 inches (approx. 0.025 mm) greater thanthe outer diameter of the hypotube 7315, which can provide stabilizationand inhibit friction. The bushing 7300 may comprise metals including,for example, platinum, titanium, nickel, chromium, cobalt, tantalum,tungsten, iron, manganese, molybdenum, alloys thereof including nickeltitanium (e.g., nitinol), nickel titanium niobium, chromium cobalt,copper aluminum nickel, iron manganese silicon, silver cadmium, goldcadmium, copper tin, copper zinc, copper zinc silicon, copper zincaluminum, copper zinc tin, iron platinum, manganese copper, platinumalloys, cobalt nickel aluminum, cobalt nickel gallium, nickel irongallium, titanium palladium, nickel manganese gallium, stainless steel,shape memory alloys, etc.

FIG. 17J is a schematic side elevational view of an example embodimentof a collet 7500. FIG. 17K is a schematic cross-sectional frontelevational view of the collet 7500 of FIG. 17J along the line 17K-17K.The collet 7500 is a holding device comprising a cylindrical innersurface including kerfs that forms an inner collar 7511 around ahypotube 7315 to be held and the cylindrical hole or aperture 7510within the inner collar 7511 exerts a clamping force or tension F_(t),measureable in Newtons or pound-feet, on the hypotube 7315 whentightened, for example by an outer collar 7512. In some embodiments, theamount of the clamping force or tension F_(t) can be measured in realtime using a tension gauge 7513. The collet 7500 may be used to assistwith holding a proximal portion 200 of a vascular treatment device, forexample the device 10, 20, 30, or 40, and releasing the proximal portion200 to be advanced forward during a laser cutting process. The amount ofclamping force or tension F_(t) can be increased or decreased bytightening or releasing the outer collar 7512, either by a manual orautomated approach.

In some embodiments, the collet 7500 includes a proximal end 7514through which an uncut hypotube 7315 is inserted, a long segment 7515within which the hypotube is held with tension F_(t) and stabilized toreduce sag (e.g., between two collets 7300, between a collet 7300 andthe bushing 7500, between the bushing 7500 and another bushing 7500),and a distal end 7504 through which the hypotube 7315 passes to beadvanced into another collet 7500 or a bushing 7300. The collet 7500includes a cylindrical hole or aperture 7510 within the inner collar7511 through which a hypotube 7315 can traverse and be stabilized frommotion during a laser cutting process. In some embodiments, thecylindrical hole 7510 has an inner diameter of at least about 0.001inches (approx. 0.025 mm) greater than the outer diameter of thehypotube 7315. In some embodiments, the collet 7500 may be split intotwo halves, and each half includes a number of nooks ranging from about1 nook to about 24 nooks (e.g., between about 1 nook and about 3 nooks,between about 5 nooks and about 7 nooks, between about 9 nooks and about11 nooks, about 3 nooks). In some embodiments, the nooks may have fullthickness 7616, wherein the nook extends fully between the outer surfaceof the inner collar 7511 to the cylindrical hole or aperture 7510 withinthe inner collar 7511, or the nooks may have partial thickness 7617,wherein the nook extends partially from outer surface of the innercollar 7511 towards the cylindrical hole or aperture 7510 but does notreach the cylindrical hole or aperture 7510. The nooks 7616 and 7617within the inner collar 7511 can allow the outer collar 7512 to reducethe diameter of the aperture 7510 within the inner collar 7511 toadequately hold hypotubes 7315 of varying diameters without usingdifferent collets 7500. The cylindrical hole or aperture 7510 within theinner collar 7511 can be tightened around the hypotube 7315 to increaseor decrease the tension, and the nooks 7616 and 7617 help adjust thetension on the hypotube 7315.

In some embodiments, the collet 7500 comprises metals such as platinum,titanium, nickel, chromium, cobalt, tantalum, tungsten, iron, manganese,molybdenum, alloys thereof including nickel titanium (e.g., nitinol),nickel titanium niobium, chromium cobalt, copper aluminum nickel, ironmanganese silicon, silver cadmium, gold cadmium, copper tin, copperzinc, copper zinc silicon, copper zinc aluminum, copper zinc tin, ironplatinum, manganese copper, platinum alloys, cobalt nickel aluminum,cobalt nickel gallium, nickel iron gallium, titanium palladium, nickelmanganese gallium, stainless steel, shape memory alloys, etc.

FIG. 17L is a schematic diagram illustrating an example embodiment of anarrangement of bushings 10160 and collets 10165. The arrangement isconfigured to hold a hypotube of a proximal portion 200 during a lasercutting process. During the laser cutting process, the hypotube 10210 isadvanced forward and held firmly in place substantially without lateralmotion when the laser beam is cutting the hypotube 10210, for example ininterspersed patterns of rows of kerfs. In some embodiments, theconcentrated laser beam is focused onto the hypotube 10210 of theproximal portion 200 via a lens 10145. Any untoward motion of thehypotube 10210 can cause slits or other patterns being cut to haveincorrect shapes or to be in incorrect locations. In the exampleillustrated in FIG. 17L, the hypotube 10210 is held in position by abushing 10160, which is configured to inhibit motion of the hypotube10210 prior to the laser beam impact, and two collets 10165, 10167configured to reduce parabolic sag of the relatively long hypotube 10210and/or can maintain adequate tension F_(t) on the hypotube 10210 as thehypotube 10210 is being advanced towards the laser beam. More or fewercollets 10165, 10167 can be used, for example depending on the length,stiffness, material, etc. of the hypotube 10210. The arrangement furtherincludes a hypotube clamp 10185 that is part of a hypotube dispenser10180. The hypotube clamp 10185 is configured to hold the hypotube 10210in position and advance the hypotube 10210 towards the laser beam.

FIG. 17M is a schematic diagram illustrating an example embodiment ofthe sage of a hypotube between in an arrangement of bushings and collets10162. For example, the bushings and collets 10162 can include threebushings 10165, 10167, 10169, three collets 10165, 10167, 10169, orcombinations of bushings and collets. Referring again to in FIGS. 17Aand 17L, the handling of a thin-walled relatively long hypotube (e.g.,about 7 feet, about 210 cm) can be very different from handling ofhypotubes for stents (e.g., about 1 inch, about 2.5 cm). In the exampleillustrated in FIG. 17M, the hypotube does not lay between the bushingsand collets 10162 in a perfectly straight line, but with parabolic sag10220. The arrangement of bushings and collets 10162 can reduce theparabolic sag 10220 to reduce cutting errors due to sag.

The parabolic sag 10220 can be reduce by at least one of the followingfour procedures: (1) ensure that all of the collets, bushings, and thehypotube clamp are at the exact or substantially the same height 10215and placing all of the collets, bushings, and the hypotube clamp in oron the same a horizontal plane (e.g., a flat table that may be part ofthe laser cutting system 10100); (2) optimizing the distance 10215between the collets, bushings and hypotube clamp; (3) applying variabletension F_(t) at the level of the hypotube clamp 10185; and/or (4)ensuring that the sag 10220 is no more than between about 2% and about3% of the height 10215. If the distance 10215 is too high, then theparabolic sag 20220 increases. If the distance 10215 is too short, thecost of the system 10100 can be excessively high and tends to clutterthe workspace area around the laser cutting device. The parabolic sag scan be calculated using Equation 3:s=wd ²/8F _(t)  (Eq. 3)where s is the sag 10220 of the hypotube, w is the weight of thehypotube per inch, d is the distance 10215 between collets, and F_(t) isthe tension applied to the hypotube by the hypotube clamp 10185.

FIG. 17N is a schematic diagram illustrating an example embodiment of awater inlet device 10300. The water inlet device 10300 can regulate thevelocity of the water inflow into a hypotube 7315 through a constrictivewater inlet gate 10187. The flow of water can cool the hypotube 7315during laser cutting and help remove slag created from the laser cuttingprocess. Fluids other than water may also be used, for example includingethylene glycol (e.g., to increase heat transfer), slurry (e.g., toincrease slag removal), etc.

The water inlet device 10300 includes a series of water inlet tubes orreservoirs 10370 through which the fluid flows before entering the lumenof the proximal portion 200. In some embodiments, the water inlet device10300 includes four water inlet tubes 10370: the highest water inlettubing 10320 has a fluid velocity v₄ and flows through a height h₄ thatis the sum of the distances 10340, 10335, 10330, 10325; the next highestwater inlet tube 10315 has a fluid velocity v₃ and flows through aheight h₃ that is the sum of the distances 10335, 10330, 10325; the nexthighest water inlet tube 10310 has a fluid velocity v₂ and flows througha height h₂ that is the sum of the distances 10330, 10325; the lowestwater inlet tube 10305 has a fluid velocity v₁ and flows through aheight h₁ that is the distance 10325.

At a height h₄ above the ground, the water inlet device 10300 has apressure P₄ and a fluid velocity v₄. The fluid entering the hypotube7315 through the constrictive water inlet gate 10187, which is at aheight h₁ above the ground, has a pressure P₁, and a fluid velocity v₁.As the sum of the kinetic energy per unit volume (½ ρv²), the potentialenergy per unit volume (ρgh), and the pressure energy (P) remain thesame, the density of the fluid p and the acceleration due to gravity g(980 cm/second²) remain constant, the fluid velocity v₁ entering thehypotube 7315 through the constrictive water inlet gate 10187 can becalculated using Equation 4:½ρv ₁ ² +ρgh ₁ +P ₁=½ρv ₄ ² +ρgh ₄ +P ₄  (Eq. 4)or, rearranged, v ₁ =√[v ₄ ²+1960(h ₄ −h ₁)+2(P ₄ −P ₁)/ρ]

In some embodiments, if the pressures P₁ and P₄ are equal to atmosphericpressure (P₁=P₄=P_(atm)), the height h₁ of the constrictive water inletgate 10187 is at ground level (h₁=0), and the fluid velocity v₄ isinitially at rest (v₄=0), then the fluid velocity v₁ entering thehypotube 7315 through the constrictive water inlet gate 10187 isdirectly proportional to the height h₄ of the external water inletregulator device 10300. By increasing the height h₄ of the externalwater inlet regulator device 10300, the fluid velocity v₁ can beincreased, and v₁ can be calculated in cm³/s using Equation 5:v ₁=√(1960×h ₄)  (Eq. 5)

At a height h₃ above the ground, the water inlet device 10300 has apressure P₃ and a fluid velocity v₃. At a height h₂ above the ground,the water inlet device 10300 has a pressure P₂ and a fluid velocity v₂.Adaptations of Equations 4 and 5 can be used to calculate the fluidvelocity v₁ when the fluid is in the tubes 10315, 10305, 10305.

The proximal portion 200 may have between 1 longitudinal section (e.g.,the same cut pattern) and about 100 longitudinal sections, between 1longitudinal section and about 50 longitudinal sections, or betweenabout 1 longitudinal section and about 20 longitudinal sections (e.g.,about 15 longitudinal sections), for example depending on the intendeduse. For example, a distal section of the proximal portion 200 may besturdy and torquable and a distal section of the proximal portion 200may be soft and flexible, with one or more sections therebetween. One ormore longitudinal transitional sections can be between longitudinalsections having a certain pattern, which can inhibit kinking that couldresult from a direct transition. The transitional sections can beinclude a linear or nonlinear change to the cut pattern, and, onaverage, can be the same as the average of the sections proximal anddistal thereto.

The proximal portion 200 comprises, in some embodiments, in longitudinalorder from distal to proximal, a first section, a second section, athird section, a fourth section, a fifth section, a sixth section, aseventh section, an eighth section, a ninth section, a tenth section, aneleventh section, a twelfth section, and a thirteenth section. The firstsection is about 16 inches (approx. 41 cm) long and includes a pitchbetween slits of about 0.005 inches (approx. 0.13 mm). The third sectionis about 10 inches (approx. 25 cm) long and includes a pitch betweenslits of about 0.01 inches (approx. 0.25 mm). The second section isabout 2 inches (approx. 5 cm) long and includes a pitch graduallychanging from about 0.005 inches (approx. 0.13 mm) to about 0.01 inches(approx. 0.25 mm), with an average pitch of about 0.0075 inches (approx.0.19 mm). The fifth section is about 10 inches (approx. 25 cm) long andincludes a pitch between slits of about 0.02 inches (approx. 0.51 mm).The fourth section is about 2 inches (approx. 5 cm) long and includes apitch gradually changing from about 0.01 inches (approx. 0.25 mm) toabout 0.02 inches (approx. 0.51 mm), with an average pitch of about0.015 inches (approx. 0.38 mm). The seventh section is about 10 inches(approx. 25 cm) long and includes a pitch between slits of about 0.04inches (approx. 1 mm). The sixth section is about 2 inches (approx. 5cm) long and includes a pitch gradually changing from about 0.02 inches(approx. 0.51 mm) to about 0.04 inches (approx. 1 mm), with an averagepitch of about 0.03 inches (approx. 0.76 mm). The ninth section is about10 inches (approx. 25 cm) long and includes a pitch between slits ofabout 0.08 inches (approx. 2 mm). The eighth section is about 2 inches(approx. 5 cm) long and includes a pitch gradually changing from about0.04 inches (approx. 1 mm) to about 0.08 inches (approx. 2 mm), with anaverage pitch of about 0.06 inches (approx. 1.5 mm). The eleventhsection is about 10 inches (approx. 25 cm) long and includes a pitchbetween slits of about 0.16 inches (approx. 4.1 mm). The tenth sectionis about 2 inches (approx. 5 cm) long and includes a pitch graduallychanging from about 0.08 inches (approx. 2 mm) to about 0.16 inches(approx. 4.1 mm), with an average pitch of about 0.12 inches (approx. 3mm). The thirteenth section is about 6 inches (approx. 15 cm) long andincludes no slits. The twelfth section is about 2 inches (approx. 5 cm)long and includes a pitch gradually changing from about 0.16 inches(approx. 4.1 mm) to no slits, with an average pitch of about 0.24 inches(approx. 6.1 mm). The pitches may have a tolerance of ±0.0005 inches(approx. 0.013 mm). The lengths of the sections may have a tolerance of±0.25 inches (approx. 6.4 mm). The proximal portion 200 may have alength of about 84 inches (approx. 210 cm). A distal-most section distalto the first section of the proximal portion 200 (e.g., about 2 mm toabout 4 mm) may remain uncut for coupling to the distal portion 100 atthe joint 300.

Although the patterns are illustrated in certain figures herein as beinggenerally horizontal or perpendicular to the longitudinal axis of thetubular structure 202, the slits 204 may be angled, for example betweenabout 95° and about 115° from the longitudinal axis of the tubularstructure 202. In some embodiments, an angle greater than 90° (up toabout 180°) can help to translate torque applied to a proximal segmentof the proximal portion 200 during rasping by spreading force acrossstems and uncut portions of the tubular structure 202. In someembodiments, an angle greater than 90° can reduce the duration ofcutting the slits 204 in the tubular structure 202.

In some embodiments, the proximal portion 200 is formed by laser cuttinga hypotube. For example, at least the proximal end of a hypotube may beclamped for treatment in a laser cutting device that has been programmedwith a desired pattern (e.g., interpersed staggered offset patterns asdescribed herein). The distal end may also be clamped in someembodiments. A laser is directed at material to be removed. In someembodiments, the distal end of the proximal portion 200 is not cut toform a bonding zone for coupling the proximal portion 200 to a distalportion 100. The bonding zone may have a length between about 1 mm andabout 4 mm (e.g., about 2 mm). The section of the proximal portion 200proximal to the proximal end of the cut pattern may be trimmed (e.g., toprovide the proximal portion 200 with a specific length, to fit intopackaging, etc.), or may remain uncut, for example to reducemanufacturing steps, since that secotion of the proximal portion 200 isintended to be outside of a body during a procedure. The proximal end ofthe proximal portion 200 may be coupled to a handle, coated, etc. forincreased manipulability by a user.

Interrupted spiral cut hypotubes may suffer from similar issues as 90degree alternating slotted hypotubes. Certain strut patterns andinterspersed patterns (e.g., the struts in Patterns A and B, whichinclude staggered and offset struts) described herein may be adapted foruse by interrupting a spiral cut in a hypotube. In certain suchembodiments, the hypotube does not incldue discrete rows including twokerfs, but include kerfs of varying circumferential widths depending onthe desired pattern of struts.

Although certain embodiments described herein are with respect tocutting a tubular structure 202, a flat sheet may also be cut and thenrolled into a tubular member, and optionally heat set to retain thetubular shape. For example, FIGS. 16E and 16F can represent either anexample of a cut pattern on a sheet or the cut pattern of a flattenedtube.

In some embodiments, the proximal portion 200 may comprise somethingother than or in addition to a tubular member. For example, the proximalportion 200 may comprise a braided structure or a hybrid of a braidedstructure and a tubular member. Certain such structures may have thesame or similar, or different, characteristics (e.g., dimensions,variable flexibility, etc.) as the tubular member described in detailherein and/or the textile structure (e.g., filament material, weavepattern, etc.) 158 described in detail with respect to the distalportion 100 herein.

In embodiments in which the proximal portion 200 is homogenous (e.g.,being a single hypotube or braided structure), the proximal portionincludes zero attachment points. For example, the proximal portion maycomprise a single integral hypotube with a plurality of cut patternsand/or shape setting along a longitudinal length. For another example,the proximal portion may comprise a single integral textile structurewith a plurality of weave parameters and/or shape setting along alongitudinal length. Homogenous proximal portions 200 can also includeone attachment point or a plurality of attachment points. For example, aplurality of sections of hypotube each having different pattern spacingmay be coupled. For another example, a plurality of sections of hypotubeeach having different shape setting (e.g., with or without a cutpattern) may be coupled. Can have no pitch (straight wires) or pitch(length to complete a circumference). Pitch can be different for eachlongitudinal section, which can help with heat setting duringmanufacturing. Pitch can also help with x-ray length measurement.Lengths of longitudinal sections can vary.

FIG. 18A is a schematic perspective view of a proximal portion 280 of avascular treatment device comprising a plurality of filaments 282. Thefilaments 282 are braided together, for example as described herein withrespect to embodiments of distal portions 100. FIG. 18B is a frontperspective view of the proximal portion 280. In some embodiments, forexample for use in the neurovasculature, the filaments may have adiameter between about 0.35 mm and about 0.65 mm (e.g., between about0.4 mm and about 0.45 mm), between about 0.1 mm and about 0.34 mm (e.g.,between about 0.25 mm and about 0.33 mm), about 0.00125 inches (approx.0.317 mm). In some embodiments, for example for use in the peripheralvasculature, the filaments may have a diameter between about 0.5 mm andabout 10 mm. Filament materials, shape memory characteristics, braidpatterns, oxidation state, etc. may be the same or similar to thosedescribed herein with respect to the distal portion 100, or may beadapted for the proximal portion 200. For example, the filaments maycross at a smaller angle (e.g., between about 1° and about 45° (e.g.,about) 17°). For other examples, the porosity may be smaller, thedensity may be larger (e.g., between about 5 PPI and about 50 PPI (e.g.,about 32 PPI)), the number of filaments may be more or fewer, thefilaments may be thicker or thinner, the radiopacity may be different,the shape memory characteristics may be different, etc.

FIG. 18C is a perspective view of another example embodiment of aproximal portion 7700 of a vascular treatment device comprising aplurality of filaments 282. The filaments 282 are not braided. Forexample, the filaments 282 may be spiraled or helically wound in onedirection (e.g., allowing torsional rasping in a first direction), in anopposite direction (e.g., allowing torsional rasping in a seconddirection), not at all (e.g., filaments 282 parallel to the longitudinalaxis, as shown in FIG. 18C), and combinations thereof (e.g., coaxialhelically wound filaments 282). In some embodiments, the plurality offilaments 282 includes shape memory filaments and radiopaque filaments,combinations thereof, and the like. The embodiment illustrated in FIG.18C includes 12 filaments 282 that are parallel to the longitudinalaxis. Although some examples of the proximal portion 7700 with 12filaments 282 are provided herein, some embodiments of the proximalportion 200 may include between about 6 filaments and about 120filaments in accordance with the values provided above and/or proximalportion may include about 6 filaments to about 96 filaments, about 6filaments to about 72 filaments, about 6 filaments to about 12filaments, and about 48 filaments.

FIG. 18D is a schematic side elevational view of an example embodimentof a proximal portion 7800 of a vascular treatment device illustratingan example pattern of radiopaque filaments, for example under x-ray. theproximal portion 7800 may be the proximal portion 200 of the device 10,20, 30, or 40. The proximal portion 7800 includes, in an expanded state,a plurality of filaments that are spirally or helically wound in onedirection. The plurality of filaments includes shape-memory filamentsand radiopaque filaments. In some embodiments, the proximal portion 7800includes, in an expanded state, two radiopaque filaments 7811, 7813 thatare interlaced in the form a double sine wave like a “double helix” atleast under x-ray. The pattern of radiopacity can allow an operator of adevice comprising the proximal portion 7800 to visualize identify theproximal portion 7800 under x-ray. In some embodiments, the double helixincludes troughs and peaks, for example at the sides of the proximalportion 7800 that the double helix at least partially creates. In FIG.18D, distances 7830, 7840, 7850, 7860, 7870 between helical intersectionpoints 7825, 7835, 7845, 7855, 7865, 7875 have substantially uniformdimensions, which can allow the proximal portion 7800 to serve as anangiographic measurement ruler. For example, the distances 7820 can helpmeasure the length of blood clots, the neck of an aneurysm, the lengthof a stenosis, etc.

FIG. 18E is a schematic front elevational view of the proximal portion7800 of FIG. 18D. In FIG. 18E, the material of the filaments isindicated by shading: filaments with no shading include shape-memorymaterial and filaments 7811, 7813 with hatched shading includeradiopaque material. The example set up of radiopaque filaments 7811,7813 illustrated with respect to FIG. 18E can generate a pattern ofradiopacity described in FIG. 18D, for example a double sine wave ordouble helix pattern. The radiopaque filaments 7811, 7813 form two sinewaves, which are offset by about 180°, and the sine waves in each pairare offset from the other filaments by about 30°. Although some examplesof the proximal portion 7800 including 12 filaments are provided herein,some embodiments of the proximal portion 200 may include between about 6filaments and about 120 filaments in accordance with the values providedabove and/or the proximal portion 200 may include about 6 filaments toabout 96 filaments, about 6 filaments to about 72 filaments, about 6filaments to about 12 filaments, and about 48 filaments, and the numberand/or percentage of radiopaque filaments can remain as described above.

FIG. 18F is a schematic side elevational view of another exampleembodiment of a proximal portion 7900 of a vascular treatment deviceillustrating an example pattern of radiopaque filaments, for exampleunder x-ray. The proximal portion 7900 may be the proximal portion 200of the device 10, 20, 30, or 40. The proximal portion 7900 includes, inan expanded state, a plurality of filaments that are spirally orhelically wound in one direction. The plurality of filaments includesshape-memory filaments and radiopaque filaments. In some embodiments,the proximal portion 7900 includes, in an expanded state, two pairs7910, 7920 of radiopaque filaments 7911, 7913 and 7915, 7917,respectively. The first pair 7910 of radiopaque filaments 7911, 7913 andsecond pair 7920 of radiopaque filaments 7915, 7917 are interlaced inthe form a paired double sine wave like a “dual double helix” at leastunder x-ray. The pattern of radiopacity can allow an operator of adevice comprising the proximal portion 7900 to visualize identify theproximal portion 7900 under x-ray. In some embodiments, the dual doublehelix includes troughs and peaks, for example at the sides of theproximal portion 7900 that the dual double helix at least partiallycreates. In FIG. 18F, distances 7930, 7940, 7950, 7960 betweenintersection points 7935, 7945, 7955, 7965, 7975 have substantiallyuniform dimensions, which can allow the proximal portion 7900 to serveas an angiographic measurement ruler. For example, the distances 7970can help measure the length of blood clots, the neck of an aneurysm, thelength of a stenosis, etc.

FIG. 18G is a schematic front elevational view of the proximal portion7900 of FIG. 18F. In FIG. 18G, the material of the filaments isindicated by shading: filaments with no shading include shape-memorymaterial and filaments 7911, 7913, 7915, 7917 with hatched shadinginclude radiopaque material. The example set up of radiopaque filaments7911, 7913, 7915, 7917 illustrated in FIG. 18G can generate a pattern ofradiopacity described with respect to FIG. 18F, for example a paireddouble sine wave or dual double helix pattern. The radiopaque filaments7911, 7913, 7915, 7917 form four sine waves, pairs 7910, 7920 of whichare offset by about 180°, and the sine waves in each pair 7910, 7920 areoffset from each other by about 30°. Although some examples of theproximal portion 7900 including 12 filaments are provided herein, someembodiments of the proximal portion 200 may include between about 6filaments and about 120 filaments in accordance with the values providedabove and/or the proximal portion 200 may include about 6 filaments toabout 96 filaments, about 6 filaments to about 72 filaments, about 6filaments to about 12 filaments, and about 48 filaments, and the numberand/or percentage of radiopaque filaments can remain as described above.

FIG. 18H is a schematic side elevational view of still another exampleembodiment of a proximal portion 8000 of a vascular treatment deviceillustrating an example pattern of radiopaque filaments, for exampleunder x-ray. The proximal portion 8000 may be the proximal portion 200of the device 10, 20, 30, or 40. The proximal portion 8000 includes, inan expanded state, a plurality of filaments that are spirally orhelically wound in one direction. The plurality of filaments includesshape-memory filaments and radiopaque filaments. In some embodiments,the proximal portion 8000 includes, in an expanded state, two pairs8010, 8020 of radiopaque filaments 8011, 8012, 8013 and 8015, 8017,8019, respectively. The first pair 8010 of radiopaque filaments 8011,8012, 8013 and the second pair 8020 of radiopaque filaments 8015, 8017,8019 are interlaced in the form a paired triple sine wave like a“reinforced double helix” at least under x-ray. The pattern ofradiopacity can allow an operator of a device comprising the proximalportion 8000 to visualize identify the proximal portion 8000 underx-ray. In some embodiments, the reinforced double helix includes troughsand peaks, for example at the sides of the proximal portion 8000 thatthe reinforced double helix at least partially creates. In FIG. 18H,distances 8030, 8040 between intersection points 8035, 8045, 8055 havesubstantially uniform dimensions, which can allow the proximal portion8000 to serve as an angiographic measurement ruler. For example, thedistances 8050 can help measure the length of blood clots, the neck ofan aneurysm, the length of a stenosis, etc.

FIG. 18I is a schematic diagram illustrating a front elevational view ofthe proximal portion 8000 of FIG. 18H. In FIG. 18I, the material of thefilaments is indicated by shading: filaments with no shading includeshape-memory material and filaments 8011, 8012, 8013, 8015, 8017, 8019with hatched shading include radiopaque material. The example set up ofradiopaque filaments 8011, 8012, 8013, 8015, 8017, 8019 illustrated inFIG. 18I can generate a pattern of radiopacity described in FIG. 18H,for example a paired triple sine wave or reinforced double helixpattern. The radiopaque filaments 8011, 8012, 8013, 8015, 8017, 8019form pairs 8010, 8020 of three sine waves that are offset by about 180°,and the sine waves in each pair 8010, 8020 are offset from each other byabout 30°. Although some examples of the proximal portion 8000 including12 filaments are provided herein, some embodiments of the proximalportion 200 may include between about 6 filaments and about 120filaments in accordance with the values provided above and/or theproximal portion 200 may include about 6 filaments to about 96filaments, about 6 filaments to about 72 filaments, about 6 filaments toabout 12 filaments, and about 48 filaments, and the number and/orpercentage of radiopaque filaments can remain as described above.

FIG. 18J is a schematic side elevational view of yet another exampleembodiment of a proximal portion 8100 of a vascular treatment deviceillustrating an example pattern of radiopaque filaments, for exampleunder x-ray. The proximal portion 8100 may be the proximal portion 200of the device 10, 20, 30, or 40. The proximal portion 8100 includes, inan expanded state, a plurality of filaments that are spirally orhelically wound in one direction along the central longitudinal axis8140 at a diameter 8150. The plurality of filaments includesshape-memory filaments and radiopaque filaments. In some embodiments,the proximal portion 8100 includes, in an expanded state, threeradiopaque filaments 8111, 8112, 8113 that are interlaced in the form athree phase sine wave like a “three phase helix” at least under x-ray.The pattern of radiopacity can allow an operator of a device comprisingthe proximal portion 8100 to visualize and identify the proximal portion8100 under x-ray. In some embodiments, the three phase helix includestroughs and peaks, for example at the sides of the proximal portion 8100that the three phase helix at least partially creates.

In some embodiments, the first radiopaque filament 8111 forms a sinewave having a phase A, the second radiopaque filament 8112 forms a sinewave having a phase B, and the third radiopaque filament 8113 forms asine wave having a phase C. In some embodiments, the three phase helixincludes troughs and peaks, for example at the sides of the distalportion 8100 that the three sine waves at least partially create.Embodiments comprising a three phase sine wave include three pitches:the sine wave formed by the radiopaque filament 8111 has a pitch 8121,the sine wave formed by the radiopaque filament 8112 has a pitch 8122,and the sine wave formed by the radiopaque filament 8113 has a pitch8123. FIG. 18J shows the pitches 8121, 8122, 8123 as the distancesbetween the lower peaks of the respective sine waves. In the embodimentillustrated in FIG. 18J, the pitches of the sine waves formed by theradiopaque filaments 8111, 8112, 8113 have substantially uniformdimensions (e.g., pitches), although the sine waves may have differingdimensions (e.g., pitches).

In some embodiments, the distance between each trough or peak of aradiopaque filament 8111, 8112, 8113 with another trough or peak of anadjacent radiopaque filament of the three phase helix is called a phaseshift. In FIG. 18J, phase A is offset from phase B by about 7.5° (shownby the distance 8131), phase B is offset from phase C by about 7.5°(shown by the distance 8132), and phase A is offset from phase C byabout 15° (shown by the distance 8133). FIG. 18J shows the phase shits8131, 8132, 8133 as the distances between the upper peaks of therespective sine waves. The pattern of radiopacity can allow an operatorof a device comprising the proximal portion 8100 to visualize andidentify the proximal portion 8100 at least under x-ray. In FIG. 18J,the intersection points along the three phase double helix aresubstantially uniformly spaced by distances 8141 or multiples thereof,which can allow the proximal portion 8100 to serve as an angiographicmeasurement ruler. For example, the distance 8141 can help an operatorto measure the length of blood clots, the neck of an aneurysm, thelength of a stenosis, etc.

FIG. 18K is a schematic front elevational view of the proximal portion8100 of FIG. 18J. In FIG. 18K, the material of the filaments isindicated by shading: filaments with no shading include shape-memorymaterial and filaments 8111, 8112, 8113 with hatched shading includeradiopaque material. The example set up of radiopaque filaments 8111,8112, 8113 illustrated in FIG. 18K can generate a pattern of radiopacitydescribed in FIG. 18J, for example a three phase helix pattern, or apattern in which the radiopaque filaments 8111, 8112, 8113 form threesine waves offset by about 120°.

FIG. 18L is a schematic side elevational view of still yet anotherexample embodiment of a proximal portion 8200 of a vascular treatmentdevice illustrating an example pattern of radiopaque filaments, forexample under x-ray. The proximal portion 8200 may be the proximalportion 200 of the device 10, 20, 30, or 40. The proximal portion 8200includes a textile structure including shape-memory filaments andradiopaque filaments. The proximal portion 8200 includes, in an expandedstate, radiopaque filaments 8211, 8212, 8213 that are interlaced in theform a paired three phase helix at least under x-ray. The filament 8211is reinforced with a second radiopaque filament and the proximal portion8200 may include additional radiopaque filaments that arenon-reinforced. The pattern of radiopacity can allow an operator of adevice comprising the proximal portion 8200 to visualize identify theproximal portion 8200 at least under x-ray. In some embodiments, thepaired three phase helix includes troughs and peaks, for example at thesides of the proximal portion 8200 that the paired three phase helix atleast partially create. A paired three phase helix includes a pitch foreach reinforced filament (e.g., a pitch 8221 for the sine wave createdby the filaments 8211) and a pitch for each non-reinforced filament(e.g., a pitch 8222 for the sine wave created by the filament 8212, apitch 8223 for the sine wave created by the filament 8213). In FIG. 18L,the intersection points along the paired triple helix are substantiallyuniformly spaced, which can allow the proximal portion 8200 to serve asan angiographic measurement ruler. For example, the distances betweenintersections can help an operator to measure the length of blood clots,the neck of an aneurysm, the length of a stenosis, etc.

FIG. 18M is a schematic front elevational view of the proximal portion8200 of FIG. 18L. In FIG. 18M, the material of the filaments isindicated by shading: filaments with no shading include shape-memorymaterial and filaments 8211, 8212, 8213 with hatched shading includeradiopaque material. The example set up of radiopaque filaments 8211,8212, 8213 illustrated in FIG. 18M, will generate a pattern ofradiopacity described in FIG. 18L, for example a reinforced three phasehelix, or a pattern in which the radiopaque filaments offset by about120°, and the radiopaque filaments 8211 within the reinforced sine waveare offset by about 30°.

FIG. 18N is a schematic side elevational view of another exampleembodiment of a proximal portion 8400 of a vascular treatment devicecomprising a plurality of filaments 156 braided together with uniformbraid angle and pore size. In some embodiments, the braid angle, thePPI, and the pore size may be uniform or variable across the length ofthe proximal portion 8400.

In some embodiments in which the proximal portion 200 comprises aplurality of filaments, radiopaque markers as described above withrespect to a distal end of the distal portion 100 (e.g., dip-coatedpolymer with radiopaque particles) may be used instead of or in additionto a radiopaque marker band 25.

As discussed above, a knitted structure (e.g., comprising transversewires) may be more rigid than a woven structure and more suitable for aproximal portion 200. In certain such embodiments, a woven or knittedproximal portion 200 and a woven distal portion 100 may comprise atleast some of the same filaments, with at least one parameter (e.g.,existence of transverse filaments, weave pattern, etc.) changing betweenthe proximal portion 200 and the distal portion 100 and/or along thelength of the proximal portion 200 (e.g., to longitudinally varyflexibility).

In some embodiments, the proximal portion 200 comprises a hybrid of abraided structure and a patterned hypotube. In certain such embodiments,the number of attachment points between different sections of theproximal portion is at least 1. In some embodiments, the length of ahypotube section of the proximal portion 200 is between about 0.1 cm andabout 60 cm (e.g., between about 30 cm and about 60 cm) and the lengthof a braided section of the proximal portion 200 is between about 20 cmand about 209.9 cm (e.g., between about 150 cm and about 180 cm). Inembodiments in which length of the hypotube section is between about 1mm and about 10 mm, the hypotube section can act as a bridge between thedistal portion 100 and the proximal portion 200. In certain suchembodiments, the hypotube may be uncut, for example because the shortlength may provide adequate flexibility at that section.

In some embodiments, the proximal portion 200 comprises a cut tube asdescribed herein, and the distal portion 100 comprises a device such asa vascular treatment device homogenously or integrally cut (e.g., fromthe same tube or sheet) or cut separately and then attached to theproximal portion 200.

FIG. 19A is a schematic diagram illustrating an example embodiment ofvariation of slits along the length of an example embodiment of aproximal portion 260. The schematic nature of FIG. 19A is apparent, forexample, by the illustration of the slits as being incomplete (showingonly one slit half) and having stems that are substantially aligned. Theproximal portion 260 includes a first longitudinal section 262 includingslits 263, a second longitudinal section 264 including slits 265, athird longitudinal section 266 including slits 267, and a fourthlongitudinal section 268 including slits 269. In the first longitudinalsection 262, the slits 263 are spaced apart by a distance d₁. In thesecond longitudinal section 264, the slits 265 are spaced apart by adistance d₂. In the third longitudinal section 266, the slits 267 arespaced apart by a distance d₃. In the fourth longitudinal section 268,the slits 269 are spaced apart by a distance d₄. The distance d₄ isgreater than the distance d₃, which is greater than the distance d₂,which is greater than the distance d₁. The variation in the distancesd₁, d₂, d₃, d₄ can affect the flexibility of the proximal portion 260,in which a shorter distance provides more flexibility and a longerdistance provides less flexibility. The first longitudinal section 262is more flexible than the second longitudinal section 264, which is moreflexible than the third longitudinal section 266, which is more flexiblethan the fourth longitudinal section 266. Although some examples of theproximal portion 200 with 4 longitudinal sections are provided herein,some embodiments of the proximal portion 200 may include between about 1longitudinal section and about 15 longitudinal sections, in accordancewith the values provided above and/or proximal portion may include about2 longitudinal sections to about 4 longitudinal sections, about 6longitudinal sections to about 8 longitudinal sections, about 10longitudinal sections to about 12 longitudinal sections, and about 13longitudinal sections.

Referring again to FIGS. 2A, 2B, 3A, 3B, 4A, 4B, and 5D-5G, in someembodiments, a radiopaque marker band 25 is welded (e.g., butt welded,laser welded), bonded, and/or soldered to the distal end of the proximalportion 200. The marker band 25 can help distinguish the distal end ofthe proximal portion 200 and the proximal end of the distal portion 100and/or to identify the joint 300. In some embodiments, a ring (e.g.,comprising platinum and/or other radiopaque material) is welded (e.g.,laser-welded) to the distal end of the proximal portion 200 using aplurality of rivets. For example, the ring may be welded using tworivets circumferentially spaced about 180° apart.

FIG. 19B is a schematic diagram illustrating an example embodiment ofvariation of slits and radiopaque markers along the length of an exampleembodiment of a proximal portion 8500 of a vascular treatment device.The proximal portion 8500 may be the proximal portion 200 of the device10, 20, 30, or 40. In some embodiments, a radiopaque marker band iswelded (e.g., butt welded, laser welded), bonded, and/or soldered to theproximal portion 200 at regular intervals, which may help to measureclot length (e.g., because the length of the distal portion 100 isknown). In some embodiments, as illustrated in FIG. 19B, radiopaquematerial is attached (e.g., laser welded) like “rivets” into the slits8535 of the proximal portion 8500 at regular intervals and interspersedwith slits 8545 that are not filled with radiopaque material or rivets,which may help to measure clot length (e.g., because the length of thedistal portion 100 is known) or to measure the degree or length of astenosis in a vessel, or to measure the diameter of a vessel or tomeasure the dimensions of an aneurysm arising from a vessel for example,measuring the neck of the aneurysm for intra-operative decision makingon device selection. Referring again to FIG. 19A, the distance betweenslits d₄ in the fourth longitudinal section 8540 of the proximal portion8500 is greater than the distance d₃ in the third longitudinal section8530 of the proximal portion 8500, which is greater than the distance d₂in the second longitudinal section 8520 of the proximal portion 8500,which is greater than the distance d₁ in the first longitudinal section8510 of the proximal portion 8500. Whether the regularly-spacedradiopaque material is a band or attached material, the radiopaquemarkers may be separated by distances of about 0.1 mm to about 50 mm,including, but not limited to, about 0.5 mm to about 1 mm, about 1 mm toabout 2 mm, about 2 mm to about 3 mm, about 3 mm to about 4 mm, about 4mm to about 5 mm, about 5 mm to about 8 mm, about 8 mm to about 10 mm,about 10 mm to about 12 mm, about 12 mm to about 15 mm, about 15 mm toabout 25 mm, about 25 mm to about 35 mm, and about 35 mm to about 50 mm,including overlapping ranges thereof. In some embodiments, indicia(e.g., numbers, radiopaque material of different dimensions, etc.) maybe used to provide further information about all or some of the markers.Although some examples of the proximal portion 8500 with 4 longitudinalsections are provided herein, some embodiments of the proximal portion200 may include between about 1 longitudinal section and about 15longitudinal sections, in accordance with the values provided aboveand/or proximal portion 200 may include about 2 longitudinal sections toabout 4 longitudinal sections, about 6 longitudinal sections to about 8longitudinal sections, about 10 longitudinal sections to about 12longitudinal sections, and about 13 longitudinal sections.

In some embodiments, the tubular structure 202 is cold worked or has notbeen subjected to heat treatment. In some embodiments, the tubularstructure 202 is straight annealed or undergoes heat treatment in astraight orientation, for example before or after patterning. Heattreating certain materials can impart shape memory such that theproximal portion 200 has a certain shape (e.g., straight, includingcurved sections, etc.) absent outside forces.

In some embodiments, the proximal portion 200 includes at least somesuper-elastic material that can, for example, return to a certain shapeafter bending due to stress-induced Martensite (SIM) without anyparticular change in temperature. Super-elastic materials can unbend(or, if the shape is curved, return to that curve) substantiallyinstantaneously when forces causing the bend are removed (e.g., byadvancement to different vasculature). In some embodiments, unbending ofthe proximal portion 200 is at least partially because the proximalportion 200 includes at least some shape memory material that can, forexample, return to a certain shape after bending due to heat-activatedaustenitic transformation (e.g., upon a particular change in temperaturesuch as greater than room temperature (about 25° C.), about bodytemperature (approx. 37° C.), etc.). Shape-memory materials can unbendslowly upon contact with warm fluid (e.g., blood at body temperature,warm saline).

In some embodiments, the shape memory effect can be one-way (e.g., astress-induced change in shape returns to a baseline shape upon heating,while there is no further change upon cooling). The material remembersone shape with the one-way shape memory effect, the shape at hightemperature. In some embodiments, the shape memory effect can be two-way(e.g., a stress-induced change in shape returns close to baseline shapeupon heating, while a second shape can be achieved upon cooling). Thematerial remembers two shapes with the two-way shape memory effect, afirst shape at high temperature and a second shape at low temperature.

FIG. 19C is a schematic diagram illustrating still another exampleembodiment of a proximal portion 8600 of a vascular treatment device.the proximal portion 8600 may be the proximal portion 200 of the device10, 20, 30, or 40. In some embodiments, different longitudinal sectionsof the proximal portion 8600 can include different materials and/orshape setting with different austenitic temperatures. For example, adistal section coupled to the proximal portion 8600 may be shape set toa straight configuration such that the distal section returns to astraight shape when not acted upon by vascular forces. For anotherexample, each of the longitudinal sections 8610, 8620, 8630, 8640 canhave a different shape set. In some embodiments, the distal-mostsections 8610, 8620 of the proximal portion 8600 may be significantlymartensitic, which can allow distal flexibility, and sections 8630, 8640proximal thereto can be significantly austenitic namely, which canprovide sturdiness and/or torquability. In some embodiments, at leastabout 25%, at least about 50%, or at least about 75% of the length ofthe proximal portion 8600 is martensitic. Although some examples of theproximal portion 8600 including 4 longitudinal sections are providedherein, some embodiments of the proximal portion 200 may include betweenabout 1 longitudinal section and about 15 longitudinal sections, inaccordance with the values provided above and/or proximal portion mayinclude about 2 longitudinal sections to about 4 longitudinal sections,about 6 longitudinal sections to about 8 longitudinal sections, about 10longitudinal sections to about 12 longitudinal sections, and about 13longitudinal sections.

FIG. 19D is a schematic cut away side view of another example embodimentof heat treatment device 5401. In some embodiments, the heat treatmentdevice 5401 may be similar to the heat treatment device 5400 describedwith respect to FIG. 10M. For example, the heat treatment device 5401comprises a fluidized sand bath including a detachable flange 5405 asdescribed herein. The device 5485 to be heat treated may comprise, forexample, a proximal portion 200 of device 10, 20, 30 or 40. The heattreatment device 5401 comprises portion a reel-to-reel device or spiraldispenser 5490, 5495 configured to deploy the device 5485 into thefluidized sand bath 5401 to selectively heat treat each longitudinalsection of the device 5485, for example in contrast to the devices 5435in the basket 5470. Proximal portions 200 may also be heat treated in abasket 5470 and distal portions 100 may also be heat treated by beingfed through the reel-to-reel device 5490, 5495.

FIG. 19E is a schematic partial cut away side view of a portion of theheat treatment device 5401 of FIG. 19D. In some embodiments, thematerial of the proximal portion 5485 (e.g., hypotube, textilestructure, wire) is loaded into the reel-to-reel device 5490 and thefree end of the proximal portion 5485 is passed through the hollowconduit 5475, exposes a longitudinal section loop inside the fluidizedsand bath 5401, passes through the hollow conduit 5477, and is loadedinto the reel-to-reel device 5495. In some embodiments, the reel-to-reeldevice 5490, 5495 can be rotated using a manual or automated approachsuch that the direction of motion of the reel-to-reel device 5490 is inthe direction 5492 and the direction of motion of the reel-to-reeldevice 5495 is in the direction 5496. The reel-to-reel device 5490includes a rotating handle or gear 5493 for rotating the reel-to-reeldevice 5490 in the direction 5492 either using a manual or automatedapproach. The reel-to-reel device 5495 includes a rotating handle orgear 5498 for rotating the reel-to-reel device 5495 in the direction5498 either using a manual or automated approach.

In some embodiments, the detachable flange 5405 includes detachableair-sealant rivets 5480 on the outer surface of the flange 5405, on theinner surface of the flange 5405, or on the outside surface and theinside surface of the flange 5405. The reversible attachment points ofthe air-sealant rivets 5480 to the hollow conduits 5475, 5477 mayinclude a luer lock mechanism, a ball and socket mechanism, a wire andhook mechanism, a c-shaped clasp and hook mechanism, combinationsthereof, and the like. The detachable flange 5405 and the air-sealantrivets 5480 can mete longitudinal sections the device 5485 for heattreatment in the fluidized sand bath 5401 and can permit the saferemoval of the device 5485 from the fluidized sand bath 5401, forexample for placement in a cooling bath after heat treatment.

In some embodiments, the reel-to-reel device 5490, 5495 allows differentlongitudinal sections of the device 5485 to be shape set with differentaustenitic temperatures. For example, in some embodiments, thedistal-most sections of a proximal portion 200 may be significantlymartensitic, which can allow distal flexibility, and sections proximalthereto can be significantly austenitic, which can provide sturdinessand/or torquability. For another example, some sections of a proximalportion can be shape set to take a certain shape upon cooling (e.g., astraight shape in a water bath below room temperature).

FIG. 19F is a schematic diagram illustrating still yet another exampleembodiment of a proximal portion 8700 of a vascular treatment device,for example the proximal portion 200 of the device 10, 20, 30, or 40.The proximal portion 8700 comprises a wire 8715 and a hypotube 8705 thatare fixably coupled at a joint 8710, for example as described withrespect to the joints 300 herein. In some embodiments, the joint 8710may be formed using processes such as laser welding the distal end ofthe microwire 8715 to the proximal end of the hypotube 8705, couplingthe distal end of the microwire 8715 to the proximal end of the hypotube8705 using a plurality of rivets, butt welding the distal end of themicrowire 8715 to the proximal end of the hypotube 8705, centerlessgrinding of the distal end of the microwire 8715 such that the microwire8715 can be inlayed into the inner lumen of the proximal end of thehypotube 8705 and then welded, etc. In some embodiments, the hypotube8705 includes the distal end of the proximal portion 200 and the wire8715 includes the proximal end of the proximal portion 200. In someembodiments, the length of the proximal portion 8700 may range fromabout 80 cm to about 210 cm, including the length of the hypotube 8705ranging from about 0.1 cm to about 60 cm (e.g., about 30 cm, about 60cm) and the length of the wire ranging from about 20 cm to about 209.9cm (e.g., about 150 cm, about 180 cm). In some embodiments, the hypotube8705 and the wire 8715 have an outer diameter between about 0.35 mm andabout 0.65 mm (e.g., between about 0.4 mm and about 0.45 mm), betweenabout 0.1 mm and about 0.5 mm (e.g., between about 0.25 mm and about0.33 mm (e.g., about 0.0125 inches (approx. 0.318 mm))). In someembodiments, for example for use with peripheral vasculature, thehypotube 8705 and the wire 8715 have an outer diameter between about 0.5mm and about 10 mm. Substantially the entire length, portions, or noneof the hypotube 8705 may be laser cut, for example with the interspersedkerf patterns described herein. A braided tubular structure may besubstituted for some or all of the hypotube 8705.

In some embodiments, the hypotube 8705 and/or the wire 8715 may compriseshape memory material that is shape set differently (e.g., differentaustenitic temperature, different shape, etc.) over differentlongitudinal sections. In some embodiments, the hypotube 8705 and/or thewire may be uniformly super-elastic. In some embodiments, the hypotube8705 and/or the wire may comprise non-shape memory material. In someembodiments, the hypotube 8705 and the wire 8715 may comprise the samematerial or different materials. Suitable materials for the hypotube8705 and the wire 8715 may include, for example, platinum, titanium,nickel, chromium, cobalt, tantalum, tungsten, iron, manganese,molybdenum, and alloys thereof including nickel titanium (e.g.,nitinol), nickel titanium niobium, chromium cobalt, copper aluminumnickel, iron manganese silicon, silver cadmium, gold cadmium, coppertin, copper zinc, copper zinc silicon, copper zinc aluminum, copper zinctin, iron platinum, manganese copper, platinum alloys, cobalt nickelaluminum, cobalt nickel gallium, nickel iron gallium, titaniumpalladium, nickel manganese gallium, stainless steel, shape memoryalloys, etc. Suitable materials for the hypotube 8705 and the wire 8715may also include, for example, polymers such as polylactic acid (PLA),polyglycolic acid (PGA), poly lactic co-glycolic acid (PLGA),polycaprolactone (PCL), polyorthoesters, polyanhydrides, and copolymersthereof. Suitable materials may also include alloys (e.g., nitinol,chromium cobalt, platinum tungsten, etc.) and combinations of materials(e.g., filaments with a radiopaque core or cladding in combination witha cladding or core, respectively, of a different material, a pluralityof filaments including different materials, etc.).

The proximal portion 200 can be coupled to a distal portion 200 at ajoint 300, as described in further detail herein.

The distal portion 100 and the proximal portion 200 may be coupled at ajoint 300. In some embodiments, the joint includes bonding material suchas solder or epoxy. Solder may be easier to control during manufacturingprocesses than epoxy, for example because its flow properties are verytemperature dependent. Use of solder rather than epoxy can allow adevice comprising the joint 300 to be sterilized using gamma radiation,which could damage polymers such as epoxy and which is generally lessexpensive than chemical sterilization techniques such as ethylene oxidesterilization.

The proximal end of the distal portion 100 may be coupled within thedistal end of the proximal portion 200 (e.g., filaments coupled to theinside of a hypotube) using inlay bonding. In some embodiments, inlaybonding does not increase the diameter or thickness beyond the diameteror thickness of the distal portion 100 or the proximal portion 200. Insome embodiments, inlay bonding does not reduce the flexibility belowthe flexibility of the distal portion 100 or the distal section of theproximal portion 200. The proximal end of the distal portion 100 may becoupled outside the distal end of the proximal portion 200 (e.g.,filaments coupled to the outside of a hypotube) using overlay bonding. Acombination of inlay bonding and overlay bonding is also possible (e.g.,some filaments coupled to the inside of a hypotube and some filamentscoupled to the outside of the hypotube, or at least some filamentscoupled to both the inside and outside of a hypotube). Inlay bonding mayinhibit coupling material such as solder or epoxy from flaking off. Insome embodiments comprising overlay bonding, a heat-shrink tube (e.g.,comprising a heat shrink polymer such as PTFE or PVC) may reduce therisk of material flaking and may make the outer surface more uniform(e.g., compared to round filaments on a round hypotube), but couldincrease the outer diameter of the device and/or reduce the availabilityof gamma radiation sterilization.

FIG. 20A is a schematic diagram illustrating an example embodiment of ajoint 3000 between a proximal portion 200 and a distal portion 100. Thedistal portion 100 includes a plurality of woven filaments and aproximal bulb 110 and the proximal portion 200 includes a tubularstructure 202, a plurality of slits 204, and a radiopaque marker band25, although other distal portions 100 and/or proximal portions 200(e.g., as described herein) are also possible. FIG. 20B is a schematiccross-section of the joint of FIG. 20A along the line 20B-20B. FIG. 20Aillustrates an example embodiment of an inlay bond including solder 302at the joint 3000 between the distal portion 100 and the proximalportion 200. FIGS. 20D-20F schematically illustrate a method of couplinga braided tube to a hypotube.

In some embodiments using inlay bonding, a distal end (e.g., a flareddistal end) of the proximal portion 200 may be mechanically crimpedaround the inlayed proximal end of the distal portion 100.

In some embodiments, the solder comprises a silver-based lead-freesolder including about 96.5% tin and about 2.5% silver. The solder maycomprise a eutectic solder having a solidus temperature T_(s) that issubstantially the same as the liquidus temperature T_(L) at which thesolder completely melts into a liquid (T_(s)=T_(L)), for example about221° C. (approx. 430° F.) (e.g., Indalloy #121, available from IndiumCorporation of Clinton, N.Y.). The eutectic silver-based lead-freesolder is slowly melted at a rate of between about 1° C. and about 2° C.per second (e.g., for a duration of about 50 seconds) from about 171° C.up to the liquidus temperature T_(L). Once the liquidus temperatureT_(L) has been reached, the rate of melting increases to between about2.5° C. and about 3° C. per second (e.g., for a duration of about 20seconds) from about 221° C. up to the peak melting temperature T_(m),for example between about 246° C. and about 271° C. The duration ofmelting of the silver-based lead-free solder from the liquidustemperature T_(L) to the peak melting temperature T_(m) may be less thanabout 45 seconds. The liquid solder may be injected using a precisioninjector syringe, for example as described with respect to FIGS.20A-20F. The molten solder is then rapidly cooled at a rate of less thanabout 4° C. per second (e.g., about 2° C. per second for a duration ofabout 50 seconds) from the peak melting temperature T_(m) to the coolingtemperature T_(c), which may be about 171° C., resulting in a strongsolder joint because of formation of a fine grain structure. A strongsolder joint may be useful for procedures that can place strain on thesolder joint, for example torsional rasping. Further cooling below thecooling temperature T_(c) may be performed at a extremely rapid rate ofgreater than about 4° C. per second (e.g., about 5° C. per second for aduration of about 35 seconds). The rapid cooling may be performed usinga water bath (e.g., at a temperature between about 20° C. and about 25°C.) for a duration of between about 30 seconds and about 120 seconds.The water bath may remove flux that was used in the soldering process.The tensile strength of a joint achievable with using silver-basedlead-free solder is relatively high at about 5800 psi. If the eutecticsilver-based lead-free solder is rapidly melted at a rate of greaterthan about 2° C. per second (e.g., for a duration of less than 25seconds) from about 171° C. up to the liquidus temperature T_(L), thenthe solder joint strength may be compromised, for example due toformation of solder balls or beads. In some embodiments, if thesoldering is attempted at a temperature below or above the peak meltingtemperature T_(m) and/or if the duration of the melting of thesilver-based lead-free solder from the liquidus temperature T_(L) to thepeak melting temperature T_(m) is greater than about 45 seconds, thenthe solder joint strength may be compromised, for example due toformation of intermetallics.

In some embodiments, if the eutectic silver-based lead-free solder isextremely rapidly cooled at a rate of greater than about 4° C. persecond (e.g., about 5° C. per second for a duration of about 20 seconds)from the peak melting temperature T_(m) to the cooling temperatureT_(c), then the solder joint strength may be compromised, for exampleforming a joint having a tensile strength of less than about 2700 psi,for example due to formation of a coarse grain structure. Mechanicaldetachment can achieve shear strengths greater than 2700 psi, and may beuseful in vascular treatment devices in which the distal portion 100 isdesirably detachable from the proximal portion 200 at the region ofjoint 300, for example in flow diverters or flow disruptors as describedherein.

In some embodiments, the solder comprises a gold-based lead-free solderincluding about 80% gold and about 20% tin. The solder may comprise aeutectic solder having a solidus temperature T_(s) that is substantiallythe same as the liquidus temperature T_(L) at which the soldercompletely melts into a liquid (T_(s)=T_(L)), for example about 280° C.(approx. 535° F.) (e.g., Indalloy #182, available from IndiumCorporation of Clinton, N.Y.). The eutectic gold-based lead-free solderis slowly melted at a rate of between about 1° C. and about 2° C. persecond (e.g., for a duration of about 50 seconds) from about 230° C. upto the liquidus temperature T_(L). Once the liquidus temperature T_(L)has been reached, the rate of melting increases to between about 2.5° C.and about 3° C. per second (e.g., for a duration of about 20 seconds)from about 280° C. up to the peak melting temperature T_(m), for examplebetween about 305° C. and about 330° C. The duration of melting of thegold-based lead-free solder from the liquidus temperature T_(L) to thepeak melting temperature T_(m) may be less than about 45 seconds. Theliquid solder may be injected using a precision injector syringe, forexample as described with respect to FIGS. 20A-20F. The molten solder isthen rapidly cooled at a rate of less than about 4° C. per second (e.g.,about 2° C. per second for a duration of about 50 seconds) from the peakmelting temperature T_(m) to the cooling temperature T_(c), which may beabout 230° C., resulting in a strong solder joint because of formationof a fine grain structure. A strong solder joint may be useful forprocedures that can place strain on the solder joint, for exampletorsional rasping. Further cooling below the cooling temperature T_(c)may be performed at a extremely rapid rate of greater than about 4° C.per second (e.g., about 5° C. per second for a duration of about 35seconds). The rapid cooling may be performed using a water bath (e.g.,at a temperature between about 20° C. and about 25° C.) for a durationof between about 30 seconds and about 120 seconds. The water bath mayremove flux that was used in the soldering process. The tensile strengthof a joint achievable with using silver-based lead-free solder isrelatively extremely high at about 40,000 psi. If the eutecticgold-based lead-free solder is rapidly melted at a rate of greater thanabout 2° C. per second (e.g., for a duration of less than 25 seconds)from about 230° C. up to the liquidus temperature T_(L), then the solderjoint strength may be compromised, for example due to formation ofsolder balls or beads. In some embodiments, if the soldering isattempted at a temperature below or above the peak melting temperatureT_(m) and/or if the duration of the melting of the gold-based lead-freesolder from the liquidus temperature T_(L) to the peak meltingtemperature T_(m) is greater than about 45 seconds, then the solderjoint strength may be compromised, for example due to formation ofintermetallics.

In some embodiments, prior to coupling, the proximal end of the distalportion 100 and/or the distal end of the proximal portion 200 aretreated to at least partially or completely remove oxide. For example,the distal end of the proximal portion 200 may be substantiallyburr-free and/or substantially oxide-free, and the proximal end of thedistal portion 100 is etched (e.g., dipped in acid) to be substantiallyoxide-free.

In some embodiments, prior to soldering an alloy of nickel and titanium(e.g., nitinol) to nitinol or to a different material (e.g., stainlesssteel), flux (e.g., Indalloy Flux #3 or Indalloy Flux #2, both availablefrom Indium Corporation of Clinton, N.Y.) can be used to reduce nickeland titanium surface oxides. Flux #3 has an activation temperature ofbetween about 96° C. and about 343° C. and contains chlorides. Flux #2has an activation temperature of between about 100° C. and about 371° C.and does not contain zinc or heavy metal chlorides. The appropriate fluxcan be applied using a brush, a swab, a spray, combinations thereof, andthe like. After the soldering process, the flux residual can be removedby cooling and washing the solder joint in a water bath as describedherein, by adding citric acid to the water bath, by a water sonicationprocess, by mechanical scrubbing, combinations thereof, and the like.

In some embodiments in which the surface oxides of nickel and titaniumcannot be adequately removed from the distal portion 100 using flux,soldering at the joint 300 can still be performed between the distalportion 100 and a proximal portion 200 comprising a different material(e.g., stainless steel) by soldering the radiopaque filaments within thedistal portion 100 (e.g., comprising platinum tungsten, etc.) to theproximal portion 200 (e.g., comprising stainless steel). Increasing thenumber of radiopaque filaments in the distal portion 100 (e.g., tobetween about 25% and about 50% of the total number of filaments) canresult in a strong solder joint, whereas decreasing the number ofradiopaque filaments in the distal portion (e.g., to between about 5%and about 25% of the total number filaments) can result in a weak solderjoint that may be useful in devices wherein the distal portion 100 of avascular treatment device is desirably detachable from the proximalportion 200 at the region of joint 300, for example in flow diverters orflow disruptors as described herein.

In some embodiments in which filaments of the distal portion 100 and/orthe proximal portion 200 comprises nickel (e.g., including nitinolstrands), nickel oxide may be formed when the strands are heat treatedin gas including oxygen such as ambient air. Nickel oxide can inhibitsoldering of the distal portion 100 to the proximal portion 200, forexample when the distal portion 100 and the proximal portion 200comprise dissimilar materials. For example after soldering, a processfor joining a distal portion 100 including oxidized nitinol filaments toa proximal portion 200 comprising a different material may includepost-processing, polishing, and/or sandblasting, which could weaken thefilaments. Non-oxidized filaments (e.g., by performing the heattreatment in an inert atmosphere such as argon or nitrogen) cangenerally be joined to dissimilar materials without suchpost-processing, polishing, and/or sandblasting. Filaments includingother oxides (e.g., titanium oxide) may also be joined to dissimilarmaterials without such post-processing, polishing, and/or sandblasting.

Referring again to FIGS. 20A and 20D-20F, the proximal end of the distalportion 100 is inserted into the distal end of the proximal portion 200.In some embodiments, solder 302 and optionally flux are delivered from adelivery device 8810 (e.g., comprising a J-shaped tube 8815 that can beinserted through the distal-most slit 204 of the proximal portion 200)in the gap between the filaments of the distal portion 100 and thetubular structure 202 of the proximal portion 200 in a first position(e.g., as illustrated by the solder 8820 in FIG. 20E and the solder 302b in FIG. 20B), then the delivery device is rotated about 90°, thensolder 302 and optionally flux are delivered in a second position (e.g.,as illustrated by the solder 302 c in FIG. 20B), then the deliverydevice is rotated about 90°, then solder 302 and optionally flux aredelivered in a third position (e.g., as illustrated by the solder 8820in FIG. 20F and the solder 302 d in FIG. 20B), then the delivery deviceis rotated about 90°, then solder 302 and flux are delivered in a fourthposition (e.g., as illustrated by the solder 302 a in FIG. 20B), andthen the delivery device 8810 is removed and the solder 302 allowed tocool. In some embodiments, solder 302 and optionally flux are deliveredfrom a delivery device 8810 (e.g., comprising a J-shaped tube 8815 thatcan be inserted through the distal-most slit 204 of the proximal portion200, for example to serve as a precision injector syringe) in the gapbetween the filaments of the distal portion 100 and the tubularstructure 202 of the proximal portion 200 in a first position (e.g., asillustrated by the solder 8820 in FIG. 20E and the solder 302 b in FIG.20B), then the delivery device is rotated about 180°, then solder 302and optionally flux are delivered in a second position (e.g., asillustrated by the solder 8820 in FIG. 20F and the solder 302 d in FIG.20B), then the delivery device is rotated about 90°, then solder 302 andoptionally flux are delivered in a third position (e.g., as illustratedby the solder 302 a in FIG. 20B), then the delivery device is rotatedabout 180°, then solder 302 and flux are delivered in a fourth position(e.g., as illustrated by the solder 302 c in FIG. 20B), and then thedelivery device 8810 is removed and the solder 302 allowed to cool. FIG.20B shows solder 302 a, 302 b, 302 c, 302 d between the distal portion100 and the proximal portion 200 and spaced about 90° apart, which maybe formed for example by the methods described herein. The device may betilted during soldering to inhibit the solder 302 from occluding thedistal-most slit 204, which could reduce flexibility in an area whereflexibility is generally desired.

Other solder amounts and positions are also possible. For example, thesolder can be fully arcuate or in more or fewer positions (e.g., threepositions about 120° apart, five positions about 72° apart, etc.), butembodiments such as illustrated in FIG. 20B may reduce manufacturingcomplexity (e.g., because about ¼ circumference or about 90° spacing canbe an intuitive measurement). Substantially equal spacing can inhibitthe formation of uneven strengths and stresses, which could, forexample, break the joint 300 during use. Increasing the number ofpositions can reduce defects due to spacing error (e.g., the morepositions, the less effect of any one inaccurate position), but increasethe manufacturing complexity (e.g., using smaller angles, less solderper delivery, more precise spacing, etc.). The amount and placement ofsolder may affect strength (e.g., more solder generally increasesstrength, which may be beneficial to uses such as torsional rasping)and/or flexibility (e.g., more solder generally reduces flexibility,which may be disadvantageous for maneuverability). Embodiments includinglocalized bonding agent 302 (e.g., as illustrated in FIGS. 20A and 20B)have been found to have good flexibility without compromising strength.

FIG. 20C is a schematic cross-section illustrating and exampleembodiment of filament 156 area in comparison to tubular structure 202area. The filaments 156 of the distal portion 100 each have an areaπd_(f) ²/4, where d_(f) is the diameter of the filament 156. The insideof the proximal portion 200 has an area πd_(h) ²/4, where d_(h) is theinner diameter of the tubular structure 202. The area of the inside ofthe tubular structure 202 not occupied by a filament 156 isapproximately π(d_(h) ²−nd_(f) ²)/4, where n is the number of filaments156. For example, if the distal portion 100 comprises 48 filaments 156each having a diameter of 0.001 inches (approx. 0.025 mm) and theproximal portion 200 comprises a tubular structure 202 having an innerdiameter of 0.01 inches (approx. 0.25 mm), the area not occupied by afilament 156 is π(0.25²−48×0.025²)/4=0.026 mm². The ratio of the areaoccupied by filaments 156 to the inner area of the tubular structure 202is πd_(f) ²/d_(h) ². For example, if the distal portion 100 comprises 48filaments 156 each having a diameter of 0.001 inches (approx. 0.025 mm)and the proximal portion 200 comprises a tubular structure 202 having aninner diameter of 0.01 inches (approx. 0.25 mm), the ratio is48×0.025²/0.25²=0.48 or 48%.

Using the length of the joint 3000 and the area available for filaments156, a volume of bonding agent (e.g., the solder 302) may be determined.If bonding agent is only to be between the outside of the filaments 156and the inside of the tubular structure 202, even less area isavailable, with the area of the proximal neck of the distal portion 100subtracted. In some embodiments, between about 45% and about 60% (e.g.,between about 51% and about 55%) of the cross-sectional area between thedistal portion 100 and the proximal portion 200 is bonding agent. If thefilaments 156 have different shapes and/or dimensions, the formulae canbe appropriately adjusted.

FIG. 21A is a schematic diagram illustrating another example embodimentof a joint 3100 between a proximal portion 200 and a distal portion 100.The distal portion 100 includes a plurality of woven filaments 156 and aproximal bulb 110 and the proximal portion 200 includes a tubularstructure 202 and a plurality of slits 204, although other distalportions 100 and/or proximal portions 200 (e.g., as described herein)are also possible. FIG. 21B is a schematic cross-section of the joint3100 of FIG. 21A along the line 21B-21B. FIG. 21A illustrates an exampleembodiment of an inlay bond including epoxy 304 at the joint 3100between the distal portion 100 and the proximal portion 200.

The proximal end of the distal portion 100 is inserted into the distalend of the proximal portion 200. In some embodiments, epoxy is deliveredfrom a delivery device (e.g., a J-shaped tube inserted through thedistal-most slit 204 of the proximal portion 200) in the gap between thefilaments of the distal portion 100 and the tubular structure 202 of theproximal portion 200 in a first position, then the delivery device isrotated about 180°, then epoxy 304 is delivered in a second position,and then the delivery device is removed and the epoxy 304 allowed todry. FIG. 21B shows epoxy 304 a, 304 b between the distal portion 100and the proximal portion 200 and spaced about 180° apart and epoxy 304 cbetween the filaments, as epoxy tends to flow. FIG. 21A also shows theepoxy 304 having flowed down around the proximal end of the distalportion 100. Excess epoxy 304 may optionally be removed using a bore orthe like. FIG. 21C is a photograph illustrating the inlay bondingapproach of FIG. 21A.

FIG. 22A is a schematic diagram illustrating yet another exampleembodiment of a joint 3200 between a proximal portion 200 and a distalportion 100. The distal portion 100 includes a plurality of wovenfilaments and a proximal bulb 110 and the proximal portion 200 includesa tubular structure 202, a plurality of slits 204, and a radiopaquemarker band 25, although other distal portions 100 and/or proximalportions 200 (e.g., as described herein) are also possible. FIG. 22B isa schematic cross-section of the joint 3200 of FIG. 22A along the line22B-22B. FIG. 22A illustrates an example embodiment of an inlay bondincluding bonding material (e.g., solder (and optionally flux) or epoxy)306 at the joint 3200 between the distal portion 100 and the proximalportion 200.

The filaments 156 at the proximal end of the distal portion 100 areinserted onto a sleeve or tube or pinch cylinder 308. The sleeve 308 maycomprise metal (e.g., a portion of a hypotube (e.g., comprisingstainless steel), platinum, titanium, nickel, chromium, cobalt,tantalum, tungsten, iron, manganese, molybdenum, alloys thereof (e.g.,nitinol, chromium cobalt, stainless steel, etc.), and combinationsthereof (e.g., cladding, banding, etc.)), polymer (e.g., a heat shrinktube), combinations thereof, and the like. In some embodiments, thesleeve 308 has a length between about 1 mm and about 5 mm. In someembodiments, the sleeve 308 has a wall thickness or a difference betweenouter diameter and inner diameter between about 0.001 inches (approx.0.025 mm) and about 0.002 inches (approx. 0.51 mm). In some embodiments,a metal sleeve 308 does not inhibit the use of gamma radiationsterilization. The filaments 156 may be pressure fit into the sleeve 308or loosely inserted into the sleeve 308. In some embodiments, the sleeve308 is clamped after insertion of the filaments 156. In some of theembodiments, at least some of the filaments 156 may be welded (e.g.,laser welded, laser butt welded, laser rivet welded, etc.) to the sleeve308.

The proximal end of the distal portion 100, including the sleeve 308, isinserted into the distal end of the proximal portion 200. In someembodiments, bonding material 306 is delivered from a delivery device(e.g., a J-shaped tube inserted through the distal-most slit 204 of theproximal portion 200) in the gap between the sleeve 308 and the tubularstructure 202 of the proximal portion 200 while rotating the deliverydevice, and then the delivery device is removed and the bonding material306 is allowed to set. FIG. 22B shows bonding material 306 between thesleeve 308 and the tubular structure 202. The bonding material 306 isshown as being arcuate, but can be in generally discrete spots, forexample as discussed above. The embodiment illustrated in FIGS. 22A and22B has been found to have a strong bond, but somewhat limitedflexibility.

Referring again to FIG. 22A, in some embodiments, the bonding material306 is between the sleeve 308 and the tubular structure 202, and beingbetween the filaments 156 and the sleeve 308 and/or between thefilaments 156 and the tubular structure 202. Bonding material 306 at thedistal end of the sleeve 308 can help secure the filaments 156 to thesleeve 308 and/or to each other.

In some embodiments in which the boding material 306 comprises epoxy,some bonding material may be below the sleeve 308, as epoxy tends toflow. FIG. 22A also shows an example of some bonding material 306 havingflowed down around the proximal end of the distal portion 100. Excessbonding material 306 may optionally be removed using a bore or the like.In some embodiments in which the bonding material 306 comprises solder,the device may be tilted during soldering to inhibit the solder 306 fromoccluding the distal-most slit 204, which could reduce flexibility in anarea where flexibility is generally desired.

FIG. 23A is a schematic diagram illustrating still another exampleembodiment of a joint 3300 between a proximal portion 200 and a distalportion 100. The distal portion 100 includes a plurality of wovenfilaments 156 and a proximal bulb 110 and the proximal portion 200includes a tubular structure 202, a plurality of slits 204, and aradiopaque marker band 25, although other distal portions 100 and/orproximal portions 200 (e.g., as described herein) are also possible.FIG. 23B is a schematic cross-section of the joint 3300 of FIG. 23Aalong the line 23B-23B. FIG. 23C is a schematic cross-section of thejoint 3300 of FIG. 23A along the line 23C-23C. FIG. 23A illustrates anexample embodiment of an inlay bond including bonding material (e.g.,solder (and optionally flux) or epoxy) 310 at the joint 3300 between thedistal portion 100 and the proximal portion 200.

The filaments 156 at the proximal end of the distal portion 100 areinserted onto a ring or pinch ring 312. The ring 312 may comprise metal(e.g., a portion of a hypotube (e.g., comprising stainless steel)),polymer (e.g., a heat shrink tube), combinations thereof, and the like.In some embodiments, a metal ring 312 does not inhibit the use of gammaradiation sterilization. The filaments 156 may be pressure fit into thering 312 or loosely inserted into the ring 312. In some embodiments, thering 312 is clamped after insertion of the filaments 156. In some of theembodiments, at least some of the filaments 156 may be welded (e.g.,laser welded, laser butt welded, laser rivet welded, etc.) to the ring312. The filaments 156 are radially outwardly frayed proximal to theproximal end of the ring 312, which can help to secure the filaments 156in the ring 312.

The proximal end of the distal portion 100, including the ring 312 andthe frayed proximal ends of the filaments 156, is inserted into thedistal end of the proximal portion 200. In some embodiments, bondingmaterial 310 is delivered from a delivery device (e.g., a J-shaped tubeinserted through the distal-most slit 204 of the proximal portion 200)in the gap between the ring 312 and the tubular structure 202 of theproximal portion 200 while rotating the delivery device, and then thedelivery device is removed and the bonding material 310 is allowed toset. FIG. 23B shows bonding material 310 between the ring 312 and thetubular structure 202. The bonding material 310 is shown as beingarcuate, but can be in generally discrete spots, for example asdiscussed above. The embodiment illustrated in FIGS. 23A-23C has beenfound to be more flexible than the embodiment illustrated in FIGS. 22Aand 22B, and the bond is nearly as strong, for example because the bondin the cross-sections illustrated in FIGS. 22B and 23B are substantiallysimilar or identical.

Referring again to FIG. 23A, in some embodiments, the bonding material310 is between the ring 312 and the tubular structure 202, and beingbetween the filaments 156 and the ring 312 and/or between the filaments156 and the tubular structure 202. Bonding material 310 at the proximalend and/or the distal end of the ring 312 can help secure the filaments156 to the ring 312 and/or to each other.

In some embodiments in which the boding material 310 comprises epoxy,some bonding material may be below the ring 312, as epoxy tends to flow.FIGS. 23A and 23C also shows an example of some bonding material 310having flowed down around the proximal end of the distal portion 100. InFIG. 23C, the frayed ends of the filaments 156 are dispersed in thebonding material 310. Excess bonding material 310 may optionally beremoved using a bore or the like. In some embodiments in which thebonding material 310 comprises solder, the device may be tilted duringsoldering to inhibit the solder 310 from occluding the distal-most slit204, which could reduce flexibility in an area where flexibility isgenerally desired.

FIG. 24A is a schematic diagram illustrating another example embodimentof a joint 3400 between a proximal portion 200 and a distal portion 100.The distal portion 100 includes a plurality of woven filaments and aproximal bulb 110 and the proximal portion 200 includes a tubularstructure 202 and a plurality of slits 204, although other distalportions 100 and/or proximal portions 200 (e.g., as described herein)are also possible. FIG. 24A illustrates an example embodiment of anoverlay bond including bonding material 320 at the joint 3400 betweenthe distal portion 100 and the proximal portion 200. The distal end ofthe proximal portion 200 is inserted into the proximal end of the distalportion 100. In some embodiments, the proximal neck of the distalportion 100 is wide enough to accept the distal end of the proximalportion 200, for example being tubular with a large enough diameter,including an outward proximal flare, etc. Adjusting the diameter ofnecks of the distal portion 100 can include, for example, using hypotubeduring a shape-setting process as described above. The distal end of theproximal portion 200 to which the distal portion 100 is bonded may bedevoid of slots 204.

FIG. 24B is a schematic diagram illustrating yet another exampleembodiment of a joint 3500 between a proximal portion 200 and a distalportion 100. The distal portion 100 includes a plurality of wovenfilaments and the proximal portion 200 includes a tubular structure 202and a plurality of slits 204, although other distal portions 100 and/orproximal portions 200 (e.g., as described herein) are also possible.FIG. 24B illustrates another example embodiment of an overlay bondincluding bonding material 320 at the joint 3400 between the distalportion 100 and the proximal portion 200. The distal end of the proximalportion 200 is inserted into the proximal end of the distal portion 100.In some embodiments, the proximal neck of the distal portion 100 is wideenough to accept the distal end of the proximal portion 200, for examplebeing tubular with a large enough diameter, including an outwardproximal flare, etc. Adjusting the diameter of necks of the distalportion 100 can include, for example, using hypotube during ashape-setting process as described above. The distal end of the proximalportion 200 to which the distal portion 100 is bonded may be devoid ofslots 204.

In some embodiments, for example the embodiment illustrated in FIG. 24Aand/or the embodiment illustrated in FIG. 24B, bonding material (e.g.,solder and optionally flux, and/or epoxy) 320 is delivered from adelivery device in the gap between the filaments of the distal portion100 and the tubular structure 202 of the proximal portion 200. Thebonding material 320 can be fully arcuate, in one position, or in aplurality of positions. Overlay bonding can be at least partiallythrough the filaments of the distal portion 100, so the control over thebonding material 320 may be greater than inlay bonding approaches. Theamount and placement of bonding material 320 may affect strength (e.g.,more bonding material 320 generally increases strength, which may bebeneficial to uses such as torsional rasping) and/or flexibility (e.g.,more bonding material 320 generally reduces flexibility, which may bedisadvantageous for maneuverability).

FIG. 24C is a schematic diagram showing the joints 3400, 3500 of FIGS.24A and 24B. The length of the joint 3400 is 322, the length of thejoint 3500 is 324, and the difference between the length of the joint3400 and the joint 3500 is 326. The length of a joint 300 may be atleast partially based on the bonding material used. For example, soldermay be stronger than epoxy such that less solder, and less length, isused. In some embodiments, the joint 3400 comprises solder and the joint3500 comprises epoxy, and FIG. 24C provides a schematic comparison ofthe longer length used based on the weaker bond of epoxy. In someembodiments, the length of a joint 300 comprising solder is about 25% toabout 50% less than the length of a joint 300 comprising epoxy (e.g.,the length 322 is about 25% to about 50% less than the length 324 and/orthe length 326 is about 25% to about 50% of the length 324). A shorterlength of the joint 300 may increase flexibility, for example byreducing the areas of the device without flexibility-imparting slots 204and/or flexible filaments.

FIG. 24D is a schematic diagram illustrating yet another exampleembodiment of a joint 3600 between a proximal portion 200 and a distalportion 100. The distal portion 100 includes a plurality of wovenfilaments and the proximal portion 200 includes a tubular structure 202and a plurality of slits 204, although other distal portions 100 and/orproximal portions 200 (e.g., as described herein) are also possible.FIG. 24D illustrates yet another example embodiment of an overlay bondincluding bonding material 320 at the joint 3600 between the distalportion 100 and the proximal portion 200. The distal end of the proximalportion 200 is inserted into the proximal end of the distal portion 100.In some embodiments, the proximal neck of the distal portion 100 is wideenough to accept the distal end of the proximal portion 200, for examplebeing tubular with a large enough diameter, including an outwardproximal flare, etc. Adjusting the diameter of necks of the distalportion 100 can include, for example, using hypotube during ashape-setting process as described above. The distal end of the proximalportion 200 to which the distal portion 100 is bonded may be devoid ofslots 204.

In some embodiments, for example the embodiment illustrated in FIG. 24D,bonding material (e.g., solder and optionally flux, and/or epoxy) 320 isdelivered from a delivery device in the gap between the filaments of thedistal portion 100 and the tubular structure 202 of the proximal portion200. The bonding material 320 can be fully arcuate, in one position, orin a plurality of positions. Overlay bonding can be at least partiallythrough the filaments of the distal portion 100, so the control over thebonding material 320 may be greater than inlay bonding approaches. Theamount and placement of bonding material 320 may affect strength (e.g.,more bonding material 320 generally increases strength, which may bebeneficial to uses such as torsional rasping) and/or flexibility (e.g.,more bonding material 320 generally reduces flexibility, which may bedisadvantageous for maneuverability).

The joint 3600 further comprises a sleeve 330. The sleeve 330 maycomprise metal (e.g., a portion of a hypotube (e.g., comprisingstainless steel)), polymer (e.g., a heat shrink tube (e.g., comprisingPET, fluoropolymer (e.g., PTFE, Viton, polyvinylidene fluoride (PVDF),fluorinated ethylene propylene (FEP), etc.), silicone rubber, polyolefin(e.g., Iridium™, available from Cobalt Polymers of Cloverdale, Calif.),PVC, Pebax® (e.g., Palladium, available from Cobalt Polymers ofCloverdale, Calif.)), combinations thereof, and the like. In someembodiments, the sleeve 330 has a length between about 1 mm and about 5mm. In some embodiments, the sleeve 330 has a wall thickness ordifference between inner diameter and outer diameter between about0.00025 inches (approx. 0.006 mm) and about 0.00125 inches (approx. 0.03mm) (e.g., about 0.0005 inches (approx. 0.013 mm), about 0.001 inches(approx. 0.025 mm)). In some embodiments, a metal sleeve 330 does notinhibit the use of gamma radiation sterilization. In some embodiments,the sleeve 330 is clamped after being placed around the proximal end ofthe distal portion 100. The sleeve 330 may inhibit bonding material 320from flaking off and/or may make the outer diameter of the joint 3600more uniform, but may increase the diameter of the device. In someembodiments, the sleeve 330 may be used without the bonding material320.

FIG. 25A-1 is a schematic diagram illustrating an example embodiment ofa mechanical detachment system 10550. FIG. 25A-2 is a schematic diagramillustrating an example embodiment of the components of the mechanicaldetachment system 10550 of FIG. 25A-1. The mechanical detachment system10550 can be used, for example, to releasably couple a distal portion100 (e.g., comprising a woven textile structure 158, which may includewoven bulbs 110) to a proximal portion 200 (e.g., comprising a tubularmember 202, which may include slits 204 and a radiopaque marker band25). The detachment system 10550 comprises a wire 11730 comprising aplurality of ridges 11732, 11734, 11736, 11738, which may be in ahorizontal or angled pattern, in an staggered interspersed pattern,combinations thereof, and the like (e.g., like the threads of a screw orthe threads of a luer lock). The ridges 11732, 11734, 11736, 11738 maybe laser cut (e.g., by removing material proximal and distal thereto).In some embodiments, the proximal end of the distal portion 100comprising a woven textile structure having various braiding patterns,for example including one-over-one-under-one, one-over-one-under-two,one-over-two-under-two, two-over-one-under-one, two-over-one-under-two,three-over-one-under-one, three-over-one-under-two,three-over-one-under-three, three-over-two-under-one,three-over-two-under-two, three-over-three-under-one,three-over-three-under-two, three-over-three-under-three,two-over-two-under-one, two-over-two-under-two, etc. In the embodimentillustrated in FIG. 25A-2, the distal portion 100 has aone-over-one-under-one braiding pattern and variable pore sizes. Thepores between the filaments 11705, 11710 create a groove 11702 intowhich the ridge 11732 can be mechanically forced, the pores between thefilament 11710 and the upper filament 11715 create a groove 11704 intowhich the ridge 11734 can be mechanically forced, the pores between thelower filament 11715 and the filament 11720 create a groove 11706 intowhich the ridge 11736 can be mechanically forced, and the pores underthe filament 11720 create a groove 11708 into which the ridge 11738 canbe mechanically forced. During desired attachment, an operator rotatesthe wire 11730 (e.g., counterclockwise). As the wire 11730 unravels(e.g., unscrews from a luer lock), the ridges 11732, 11734, 11736, 11738disengage or untangle from the grooves 11702, 11704, 11706, 11708, whichcan allow the distal portion 100 to exit the proximal portion 200.

In some embodiments, suitable materials for the wire 11730 may include,for example, platinum, titanium, nickel, chromium, cobalt, tantalum,tungsten, iron, manganese, molybdenum, and alloys thereof includingnickel titanium (e.g., nitinol), nickel titanium niobium, chromiumcobalt, copper aluminum nickel, iron manganese silicon, silver cadmium,gold cadmium, copper tin, copper zinc, copper zinc silicon, copper zincaluminum, copper zinc tin, iron platinum, manganese copper, platinumalloys, cobalt nickel aluminum, cobalt nickel gallium, nickel irongallium, titanium palladium, nickel manganese gallium, stainless steel,shape memory alloys, etc. Suitable materials may also include polymerssuch as polylactic acid (PLA), polyglycolic acid (PGA), poly lacticco-glycolic acid (PLGA), polycaprolactone (PCL), polyorthoesters,polyanhydrides, and copolymers thereof. Suitable materials may alsoinclude alloys (e.g., nitinol, chromium cobalt, platinum tungsten, etc.)and combinations of materials (e.g., filaments with a radiopaque core orcladding in combination with a cladding or core, respectively, of adifferent material, a plurality of filaments including differentmaterials, etc.).

FIG. 25B is a schematic diagram of a partial cross-sectional view of anexample embodiment of a mechanical detachment system 10600. Themechanical detachment system 10600 can be used, for example, toreleasably couple a distal portion 100 (e.g., comprising a woven textilestructure 158) to a proximal portion 200 (e.g., comprising a tubularmember 202). The detachment system 10600 comprises a shape-memory wire10555 formed into one or more shapes 10605 and optionally a coil 10610.The shape 10605 may include one or more of sphere, oblong, egg, oval,ellipse, spiral, twisted, figure-8, helical, triangle, rectangle,parallelogram, rhombus, square, diamond, pentagon, hexagon, heptagon,octagon, nonagon, decagon, quatrefoil, trapezoid, trapezium, otherpolygons, curvilinear or bulged versions of these and other shapes,combinations thereof, and the like. The wire 10555 is held by anoperator or mechanically anchored to a structure proximal to the distalportion 100. When the detachment system 10700 is at a first temperature(e.g., about 25° C.), the shape 10605 engages or entangles intersectionsof the filaments of the distal portion 100 such that the proximal end ofthe distal portion is substantially stationarily positioned in thedistal end of the proximal portion 200. When the detachment system 10600is at a second temperature (e.g., about 37° C.), the shape 10605 beginsto straighten due to the shape memory properties of the wire 10555,which has been heat treated to assume a non-shape (e.g., substantiallylinear) shape upon reaching A_(f). As the shape 10605 transforms, thewire 10555 disengages or untangles from the intersections of thefilaments of the distal portion 100, which can allow the distal portion100 to exit the proximal portion 200. When the detachment system 10600is at a first temperature (e.g., about 25° C.), the optional coil 10610is in a coiled state (e.g., as shown in FIG. 25B). When the detachmentsystem 10600 is at a second temperature (e.g., about 37° C.), the coil10610 begins to straighten due to the shape memory properties of thewire 10555, which has been heat treated to assume a non-coiled (e.g.,substantially linear) shape upon reaching A_(f). As the coil 10610straightens, the wire 10555 moves in the direction 10650, which can, forexample, indicate to a user that the one-way shape memory properties aretaking effect.

In some embodiments, the detachment system 10600 comprises ashape-memory wire 10555 formed into one or more shapes 10605 andoptionally a coil 10610. The wire 10555 is held by an operator ormechanically anchored to a structure proximal to the distal portion 100.When the detachment system 10600 is at a first temperature (e.g., about25° C.), the shape 10605 engages or entangles intersections of thefilaments of the distal portion 100 such that the proximal end of thedistal portion is stationarily positioned in the distal end of theproximal portion 200. When the detachment system 10600 is at a secondtemperature achieved upon contact with blood at body temperature (e.g.,about 37° C.), the distal portion 100 further expands to an expandedconfiguration and the shape 10605 further expands and engages orentangles intersections of the filaments of the distal portion 100 suchthat the proximal end of the distal portion is substantiallystationarily positioned in the distal end of the proximal portion 200.When the detachment system 10600 is at a third temperature achieved byhand injecting cold saline through the microcatheter or guide catheter(e.g., at about 18° C.), the shape 10605 begins to straighten due to thetwo-way shape memory properties of the wire 10555, which has been heattreated to assume a non-shape (e.g., substantially linear) shape uponreaching A_(f) (e.g., between about 10° C. and about 18° C.). As theshape 10605 unravels, the wire 10555 disengages or untangles from theintersections of the filaments of the distal portion 100, which canallow the distal portion 100 to exit the proximal portion 200. When thedetachment system 10600 is at a first temperature (e.g., about 25° C.),the optional coil 10610 is in a coiled state (e.g., as shown in FIG.25C). When the detachment system 10600 is at a second temperature (e.g.,about 37° C.), the optional coil 10610 is in a expanded coiled state(e.g., as shown in FIG. 25C). When the detachment system 10600 is at athird temperature (e.g., about 18° C.), the coil 10610 begins tostraighten due to the shape memory properties of the wire 10555, whichhas been heat treated to assume a non-coiled (e.g., substantiallylinear) shape upon reaching A_(f) (e.g., between about 10° C. and about18° C.). As the coil 10610 straightens, the wire 10555 moves in thedirection 10650, which can, for example, indicate to a user that thetwo-way shape memory properties are taking effect.

FIG. 25C is a schematic diagram of a partial cross-sectional view ofanother example embodiment of a mechanical detachment system 10700. Themechanical detachment system 10700 can be used, for example, toreleasably couple a distal portion 100 (e.g., comprising a woven textilestructure 158) to a proximal portion 200 (e.g., comprising a tubularmember 202). The detachment system 10700 comprises a shape-memory wire10557 formed into one or more balls 10615 and optionally a coil 10610.The wire 10557 is held by an operator or mechanically anchored to astructure proximal to the distal portion 100. When the detachment system10700 is at a first temperature (e.g., about 25° C.), the ball 10615engages or entangles intersections of the filaments of the distalportion 100 such that the proximal end of the distal portion issubstantially stationarily positioned in the distal end of the proximalportion 200. When the detachment system 10700 is at a second temperature(e.g., about 37° C.), the ball 10615 begins to straighten due to theshape memory properties of the wire 10557, which has been heat treatedto assume a non-ball (e.g., substantially linear) shape upon reachingA_(f). As the ball 10615 unravels, the wire 10557 disengages oruntangles from the intersections of the filaments of the distal portion100, which can allow the distal portion 100 to exit the proximal portion200. When the detachment system 10700 is at a first temperature (e.g.,about 25° C.), the optional coil 10610 is in a coiled state (e.g., asshown in FIG. 25C). When the detachment system 10700 is at a secondtemperature (e.g., about 37° C.), the coil 10610 begins to straightendue to the shape memory properties of the wire 10557, which has beenheat treated to assume a non-coiled (e.g., substantially linear) shapeupon reaching A_(f). As the coil 10610 straightens, the wire 10557 movesin the direction 10650, which can, for example, indicate to a user thatthe one-way shape memory properties are taking effect.

In some embodiments, the detachment system 10700 comprises ashape-memory wire 10557 formed into one or more shapes 10605 andoptionally a coil 10610. The wire 10557 is held by an operator ormechanically anchored to a structure proximal to the distal portion 100.When the detachment system 10700 is at a first temperature (e.g., about25° C.), the ball 10615 engages or entangles intersections of thefilaments of the distal portion 100 such that the proximal end of thedistal portion is stationarily positioned in the distal end of theproximal portion 200. When the detachment system 10700 is at a secondtemperature achieved upon contact with blood at body temperature (e.g.,about 37° C.), the distal portion 100 further expands to an expandedconfiguration and the ball 10615 further expands and engages orentangles intersections of the filaments of the distal portion 100 suchthat the proximal end of the distal portion is substantiallystationarily positioned in the distal end of the proximal portion 200.When the detachment system 10700 is at a third temperature achieved byhand injecting cold saline through the microcatheter or guide catheter(e.g., at about 18° C.), the ball 10615 begins to straighten due to thetwo-way shape memory properties of the wire 10557, which has been heattreated to assume a non-shape (e.g., substantially linear) shape uponreaching A_(f) (e.g., between about 10° C. and about 18° C.). As theball 10615 unravels, the wire 10557 disengages or untangles from theintersections of the filaments of the distal portion 100, which canallow the distal portion 100 to exit the proximal portion 200. When thedetachment system 10700 is at a first temperature (e.g., about 25° C.),the optional coil 10610 is in a coiled state (e.g., as shown in FIG.25C). When the detachment system 10700 is at a second temperature (e.g.,about 37° C.), the optional coil 10610 is in a expanded coiled state(e.g., as shown in FIG. 25C). When the detachment system 10700 is at athird temperature (e.g., about 18° C.), the coil 10610 begins tostraighten due to the shape memory properties of the wire 10557, whichhas been heat treated to assume a non-coiled (e.g., substantiallylinear) shape upon reaching A_(f) (e.g., between about 10° C. and about18° C.). As the coil 10610 straightens, the wire 10557 moves in thedirection 10650, which can, for example, indicate to a user that thetwo-way shape memory properties are taking effect.

FIG. 25D is a schematic diagram of a partial cross-sectional view of yetanother example embodiment of a mechanical detachment system 10800. Themechanical detachment system 10800 can be used, for example, toreleasably couple a distal portion 100 (e.g., comprising a woven textilestructure 158) to a proximal portion 200 (e.g., comprising a tubularmember 202). The detachment system 10800 comprises parts of the distalportion 100 and the proximal portion 200. The distal end of the proximalportion 200 comprises slits 10815, 10818, recesses, radially outwarddimples, combinations thereof, and the like. Parts 10805, 10810 of theproximal end of the distal portion 100 are mechanically forced into theslits 10815, 10818 of the proximal portion 200. As described above, thedistal portion 100 may include shape-memory filaments configured toassume a shape upon reaching a certain temperature. When the detachmentsystem 10800 is at a first temperature (e.g., about 25° C.), the parts10805, 10810 of the distal portion 100 remain in the slits 10815, 10818of the proximal portion 200. When the detachment system 10800 is at asecond temperature (e.g., about 37° C.), the sections of the distalportion 100 comprising the parts 10805, 10810 begin to straighten due tothe one-way shape memory properties of the distal portion 100, which hasbeen heat treated to assume a non-mechanically forced (e.g.,substantially cylindrical) shape upon reaching A_(f). As the section ofthe distal portion 100 straightens, the parts 10805, 10810 move out ofthe slits 10815, 10818, which can allow the distal portion 100 to exitthe proximal portion 200. Although some examples of the distal portion100 are provided herein, some embodiments of the ends of the distalportion 100 may be mechanically forced into slits from inside-out oroutside-in based on whether the embodiment refers to the distal portion100 of device 10, 20, 30 or 40.

In some embodiments, the detachment system 10800 comprises parts of thedistal portion 100 and the proximal portion 200 of a device 10, 20, 30or 40 as described herein. The distal end of the proximal portion 200comprises slits 10815, 10818, and may include recesses, radially outwarddimples, combinations thereof, and the like. Parts 10805, 10810 of theproximal end of the distal portion 100 are mechanically forced into theslits 10815, 10818 of the proximal portion 200. As described above, thedistal portion 100 may include shape-memory filaments configured toassume a shape upon reaching a certain temperature. When the detachmentsystem 10800 is at a first temperature (e.g., about 25° C.), the parts10805, 10810 of the distal portion 100 remain in the slits 10815, 10818of the proximal portion 200. When the detachment system 10800 is at asecond temperature achieved on contact with blood at body temperature(e.g., about 37° C.), the parts 10805, 10810 of the distal portion 100further expand into the slits 10815, 10818 of the proximal portion 200.When the detachment system 10800 is at a third temperature achieved byhand injecting cold saline through a microcatheter or guide catheter(e.g., at about 18° C.), the sections of the distal portion 100comprising the parts 10805, 10810 begin to straighten due to the two-wayshape memory properties of the distal portion 100, which has been heattreated to assume a non-mechanically forced (e.g., substantiallycylindrical) shape upon reaching A_(f) (e.g., between about 10° C. andabout 18° C.). As the section of the distal portion 100 straightens, theparts 10805, 10810 move out of the slits 10815, 10818, which can allowthe distal portion 100 to exit the proximal portion 200.

Although some examples of the distal portion 100 are provided herein,some embodiments of the ends of the distal portion 100 may bemechanically forced into slits from inside-out or outside-in based onwhether the embodiment refers to the distal portion 100 of device 10,20, 30 or 40. Although some examples of the proximal portion 200 areprovided herein, some embodiments of the ends of the proximal portion200 of device 10, 20, or 40 may include slits or recesses in horizontalor angled laser cut patterns, staggered interspersed patterns, laser cutpatterns of different shapes including one of sphere, oblong, egg, oval,ellipse, spiral, twisted, figure-8, helical, triangle, rectangle,parallelogram, rhombus, square, diamond, pentagon, hexagon, heptagon,octagon, nonagon, decagon, quatrefoil, trapezoid, trapezium, otherpolygons, curvilinear or bulged versions of these and other shapes,combinations thereof, and the like.

FIG. 25E is a schematic diagram of a partial cross-sectional view of anexample embodiment of a mechanical detachment system 10900. Themechanical detachment system 10900 can be used, for example, toreleasably couple a distal portion 100 (e.g., comprising a woven textilestructure 158) to a proximal portion 200 (e.g., comprising a tubularmember 202). The detachment system 10900 comprises a shape-memory wire10550 formed into a substantially linear shape or formed into one ormore shapes 10625 and optionally a coil 10610. The shapes 10625 mayinclude one of linear, sphere, oblong, egg, oval, ellipse, spiral,twisted, figure of 8 shape, helical, triangle, rectangle, parallelogram,rhombus, square, diamond, pentagon, hexagon, heptagon, octagon, nonagon,decagon, quatrefoil, trapezoid, trapezium, other polygons, curvilinearor bulged versions of these and other shapes, combinations thereof, andthe like. The proximal end of the distal portion 100 is anchored to thewire 10550 by solder (for example, a eutectic silver-based lead-freesolder). In some embodiments, if the eutectic silver-based lead-freesolder is rapidly cooled at a rate of greater than about 4° C. persecond (e.g., about 5° C. per second for a duration of about 20 seconds)from the peak melting temperature T_(m), which is between about 246° C.and about 271° C., to the cooling temperature T_(c), which is about 171°C., the joint strength is relatively weak, having a tensile strength ofless than about 2700 psi, for example due to formation of a coarse grainstructure. The wire 10550 is held by an operator or mechanicallyanchored to a structure proximal to the distal portion 100. At the timeof detachment, the operator exerts a sheer strength on the wire 10550greater than the tensile strength of the joint (e.g., greater than about2700 psi) to detach the distal portion 100 from the proximal portion200. Such detachment may be useful, for example, in devices in which thedistal portion 100 of a vascular treatment device is desirably detachedfrom the proximal portion 200 at the region of joint 300, for example,in flow diverters or flow disruptors as described herein.

In some embodiments, suitable materials for the wire 10550 may include,for example, platinum, titanium, nickel, chromium, cobalt, tantalum,tungsten, iron, manganese, molybdenum, and alloys thereof includingnickel titanium (e.g., nitinol), nickel titanium niobium, chromiumcobalt, copper aluminum nickel, iron manganese silicon, silver cadmium,gold cadmium, copper tin, copper zinc, copper zinc silicon, copper zincaluminum, copper zinc tin, iron platinum, manganese copper, platinumalloys, cobalt nickel aluminum, cobalt nickel gallium, nickel irongallium, titanium palladium, nickel manganese gallium, stainless steel,shape memory alloys, etc. Suitable materials may also include polymerssuch as polylactic acid (PLA), polyglycolic acid (PGA), poly lacticco-glycolic acid (PLGA), polycaprolactone (PCL), polyorthoesters,polyanhydrides, and copolymers thereof. Suitable materials may alsoinclude alloys (e.g., nitinol, chromium cobalt, platinum tungsten, etc.)and combinations of materials (e.g., filaments with a radiopaque core orcladding in combination with a cladding or core, respectively, of adifferent material, a plurality of filaments including differentmaterials, etc.).

FIG. 26A is a schematic diagram illustrating still another exampleembodiment of a joint 3700 between a proximal portion 200 and a distalportion 100. Such bonding can produce, for example, the device 20schematically illustrated in FIG. 1B. In contrast to FIGS. 24A, 24B, and24D, in which the joints 3400, 3500, 3600 include the proximal end ofthe distal portion 100 and the distal end of the proximal portion 200(e.g., to produce the device 10 schematically illustrated in FIG. 1A),the joint 3700 includes the distal end of the distal portion 100 and thedistal end of the proximal portion 200. The proximal portion 200 extendsthrough the hollow area created by the woven filaments of the distalportion 100. The proximal portion 200 may still be characterized asproximal because the proximal portion continues to extend proximal tothe distal portion 100. The joint 3700 may comprise the features of thejoints 3400, 3500, 3600 (e.g., bonding material 320 and/or the sleeve330).

In some embodiments, the distal ends of the filaments of the distalportion 100 may be configured to be positioned in the distal end of theproximal portion 100 (e.g., by curling radially inward). In certain suchembodiments, the joint 3700 may comprise the features of the joints3000, 3100, 3200, 3300 (e.g., bonding material, a compression sleeve, acompression ring, etc.).

In some embodiments, the proximal end of the distal portion 100 is notcoupled to the proximal portion 200 (e.g., the proximal end of thedistal portion 100 is free to move longitudinally along the proximalportion 200). In some embodiments, the proximal neck of the distalportion 100 is long (e.g., greater than about 5 mm) to inhibitunsheathing of the entire distal portion 100 during a procedure. In someembodiments, the proximal end of the distal portion 100 comprises aradiopaque marker band 1720, for example as described herein, which canwarn against and/or help inhibit unsheathing of the entire distalportion 100 during a procedure.

In some embodiments, the proximal portion 200 of a device 20 is the sameother the proximal portions 200 described herein. In some embodiments,the proximal portion 200 of a device 20 includes a longer distal-mostsegment to account for the length of the distal portion 100 (e.g., a 41mm distal-most cut section of the proximal portion 200 may be about 101mm).

The device 20 may be useful for hard clots, aged clots, and/or clotsincluding embedded plaque, for example because the entire longitudinallength of the distal portion 100 is reinforced with the strength of theproximal portion 200 and/or because proximal portion 200 can providemore direct torsional rasping to the entire length of the distal portion100 rather than the torque being diluted along the length of the distalportion 100 with distance from the proximal portion 200 in a device 10.The device 10 may be useful for acute clots and/or clots that arerelatively new.

FIG. 26B is a schematic diagram illustrating yet still another exampleembodiment of a joint 3750 between a proximal portion 100 and a distalportion 200. Such bonding can produce, for example, the device 30schematically illustrated in FIG. 1C. In contrast to FIGS. 24A, 24B, and24D, in which the joints 3400, 3500, 3600 include the proximal end ofthe distal portion 100 and the distal end of the proximal portion 200(e.g., to produce the device 10 schematically illustrated in FIG. 1A),the joint 3750 includes an intermediate part of the distal portion 100and the distal end of the proximal portion 200. The proximal portion 200extends through the hollow area created by the woven filaments of thedistal portion 100 proximal to the joint 3750. The proximal portion 200may still be characterized as proximal because the proximal portioncontinues to extend proximal to the distal portion 100. The joint 3750may comprise the features of the joints 3400, 3500, 3600 (e.g., bondingmaterial 320 and/or the sleeve 330) and other joints described herein.

In some embodiments, the proximal end of the distal portion 100 is notcoupled to the proximal portion 200 (e.g., the proximal end of thedistal portion 100 is free to move longitudinally along the proximalportion 200). In some embodiments, the proximal neck of the distalportion 100 is long (e.g., greater than about 5 mm) to inhibitunsheathing of the entire distal portion 100 during a procedure. In someembodiments, the proximal end of the distal portion 100 comprises aradiopaque marker band 1720, for example as described herein, which canwarn against and/or help inhibit unsheathing of the entire distalportion 100 during a procedure. In some embodiments, the proximalportion 200 includes a longer distal-most segment to account for thelength of the distal portion 100 through which the proximal portion 100extends (e.g., a 41 mm distal-most cut section of the proximal portion200 may be about 81 mm).

FIG. 26C is a schematic diagram illustrating another example embodimentof a joint 3775 between a proximal portion 100 and a distal portion 200.Such bonding can produce, for example, the device 40 schematicallyillustrated in FIG. 1D. In contrast to FIGS. 24A, 24B, and 24D, in whichthe joints 3400, 3500, 3600 include the proximal end of the distalportion 100 and the distal end of the proximal portion 200 (e.g., toproduce the device 10 schematically illustrated in FIG. 1A), the joint3750 includes the distal end of the distal portion 100 and anintermediate part of the proximal portion 200. The proximal portion 200extends through the hollow area created by the woven filaments of thedistal portion 100 and distal to the distal end of the distal portion100. The proximal portion 200 may still be characterized as proximalbecause the proximal portion continues to extend proximal to the distalportion 100. The joint 3775 may comprise the features of the joints3400, 3500, 3600 (e.g., bonding material 320 and/or the sleeve 330) andother joints described herein.

In some embodiments, the proximal end of the distal portion 100 is notcoupled to the proximal portion 200 (e.g., the proximal end of thedistal portion 100 is free to move longitudinally along the proximalportion 200). In some embodiments, the proximal neck of the distalportion 100 is long (e.g., greater than about 5 mm) to inhibitunsheathing of the entire distal portion 100 during a procedure. In someembodiments, the proximal end of the distal portion 100 comprises aradiopaque marker band 1720, for example as described herein, which canwarn against and/or help inhibit unsheathing of the entire distalportion 100 during a procedure. In some embodiments, the proximalportion 200 includes a longer distal-most segment to account for thelength of the distal portion 100 and the extension of the proximalportion 100 beyond the distal portion 200 (e.g., a 41 mm distal-most cutsection of the proximal portion 200 may be about 141 mm).

In some embodiments, the distal portion 100 may be joined to theproximal portion 200 between the proximal end of the distal portion 100and the distal end of the distal portion 100. For example, the joint 300may be along the neck between the distal-most bulb and the next mostdistal bulb. Certain such embodiments can provide the benefits of thedevice 20 and a distal bulb that can provide embolic protection withouta separate distal embolic protection device. For another example, thejoint 300 may be in an intermediate portion of the distal portion 100,which can provide a smaller diameter in a distal section of the distalportion 100 (e.g., useful for traversing to smaller vessels), which canprovide embolic filtering, and/or which can provide structuralreinforcement in a proximal section of the distal portion 100.

After joining the distal portion 100 and the proximal portion 200, theentire distal portion 100 and about 50% of the proximal portion 100 maybe placed within an introducer sheath. The introducer sheath maintainsthe distal portion 100 in the contracted or constrained position, andcan inhibit the distal section of the proximal portion 200 that itsurrounds from kinking. In some embodiments, the introducer sheathcomprises a biomedical polymer, for example silicone, polyurethane(e.g., Polyslix, available from Duke Extrusion of Santa Cruz, Calif.),polyethylene (e.g., Rexell®, available from Huntsman) including lowdensity polyethylene (LDPE), linear low density polyethylene (LLDPE),medium density polyethylene (MDPE), and high density polyethylene(HDPE), fluoropolymers such as fluorinated ethylene propylene, PFA, MFA,PVDF, THV, ETFE, PCTFE, ECTFE (e.g., Teflon® FEP, available fromDuPont), polypropylene, polyesters including polyethylene terephthalate(PET), PBT, PETG (e.g., Hytrel®, available from DuPont), PTFE,combination polymer compounds such as thermoplastic polyurethanes andpolyether block amides (e.g., Propell™, available from FosterCorporation of Putnam, Conn.), polyether block amides (e.g. Pebax®,available from Arkema of Colombes, France, PebaSlix, available from DukeExtrusion of Santa Cruz, Calif.), polyether soft blocks coupled withpolyester hard blocks vinyls such as PVC, PVDC, polyimides (e.g.,polyimides available from MicroLumen of Oldsmar, Fla.), polyamides(e.g., Durethan, available from Bayer, Nylon 12, available from DukeExtrusion of Santa Cruz, Calif.), polycarbonate (e.g., Corethane™,available from Corvita Corp. of Miami, Fla.), styrenics such as PS, SAN,ABS, and HIPS, acetals such as copolymers or homopolymers, hightemperature performance polymers such as PEEK, PES, PPS, PSU, LCP,combinations thereof, and the like. The introducer sheath may have atapered tip or a straight tip.

In some embodiments, a kit comprises a vascular treatment device atleast partially within an introducer sheath. The vascular treatmentdevice includes a distal portion 100 and a proximal portion 200. Thedistal portion 100 may be in a radially compressed state within theintroducer sheath. The distal portion 100 and the proximal portion 200are coupled at a joint 300. The joint may be reversible ornon-reversible. The kit may further comprise tubing in a spiral patternconfigured to contain the introducer sheath and/or a thrombusmeasurement guide (e.g., as illustrated in FIG. 27N). The thrombusmeasurement guide may be on a backing configured to hold the tubing inthe spiral pattern in a plane. Multiple planes are possible for longervascular treatment devices and/or dimensionally smaller kits.

In some embodiments, the introducer sheath has a length that is betweenabout 10% and about 50% of the length of the proximal portion 200. Insome embodiments, the introducer sheath has a length between about(e.g., about 105 cm). In some embodiments, the introducer sheath has aninner diameter between about 0.5 mm and about 0.5 mm (e.g., about 0.0165inches (approx. 0.42 mm)). In some embodiments, the introducer sheathhas an outer diameter between about 0.5 mm and about 0.75 mm (e.g.,about 0.024 inches (approx. 0.61 mm)). In some embodiments, theintroducer sheath has an inner diameter that is at least about 0.002inches (approx. 0.05 mm) greater than the outer diameter of the proximalportion 200 and/or the distal portion 100 in the collapsedconfiguration, which can inhibit or prevent premature deployment of thedistal portion 100 and/or allow easier advancing of the distal portion100. In some embodiments, the introducer sheath has an inner diameterthat is at least about 0.002 inches (approx. 0.05 mm) greater than theouter diameter of the proximal portion 200 and/or the distal portion 100in the collapsed configuration, which can inhibit or prevent prematuredeployment of the distal portion 100 and/or allow easier advancing ofthe distal portion 100 in the collapsed configuration. In someembodiments, the introducer sheath has an inner diameter that is nogreater about 0.002 inches (approx. 0.05 mm) greater than the innerdiameter of the delivery catheter or microcatheter, which can allowsmooth advancing of the distal portion 100 in the collapsedconfiguration from the introducer sheath to the microcatheter. In someembodiments, the introducer sheath has a wall thickness between about0.002 inches (approx. 0.05 mm) and about 0.006 inches (approx. 0.15 mm),which can inhibit or prevent kinking of the introducer sheath and/orprotect the distal portion 100.

The device (the distal portion 100 and the proximal portion 200) and theintroducer sheath may be placed in a protective spiral loop to inhibitany portion of the device from kinking, and then sealed in a pouch(e.g., comprising high density polyethylene). The pouch and its contentsmay be sterilized by gamma radiation and/or chemical treatment (e.g.,ethylene oxide gas), and then placed in a box for shipping.

In some embodiments, the box includes a length scale. After a procedure,a user can lay a clot next to the scale to measure the length of clot.Such a measurement can help verify that the length of the removed clotis at least as long as the length of the clot as measured prior to theremoval procedure. If the length of the measure clot is less thanexpected, the user might check the aspiration syringe for additionalclot. Certain process, such as torsional rasping described herein, cansubstantially maintain the length of the clot for accurate measurement,whereas other processes, for example in which a clot is macerated,eliminate the possibility of such measurement or cause the user to tryto stack the various pieces of the removed clot, which can beinaccurate.

The devices 10, 20, 30, 40 described herein may be used forthrombectomy, for example according to the procedures described below,but can also be used as an embolic filter, for example during anangioplasty, aspiration, stenting, or other vascular procedure such asflow diversion or flow disruption (e.g., as described herein).

Prior to performing a thrombectomy procedure, a subject having a clot isidentified. Subjects showing at least one of ten symptoms of strokereceive a computerized axial tomography (CAT) scan. The CAT scan showsif there is bleeding or no bleeding. If there is bleeding, then the areaoutside vasculature shows up as hyperdense or bright. If there is nobleeding, then the clot or blockage shows up as hyperdense or bright.

If there is a clot, the length of the clot can be measured, for example,by at least one of: (1) CAT scan print and scale or digital imagingmeasurement (PACS); (2) CAT scan angiogram where about 50 cm³ to about100 cm³ of dye comprising iodine (e.g., iohexyl, iodixanol, etc.) areinjected into a forearm vein IV and pictures of neuro blood vessels aretaken; (3) magnetic resonance imaging (MRI) angiogram where 20 cm³ toabout 40 cm³ of gadolinium are injected into a forearm vein IV andpicture are taken of neuro blood vessels, which can also provide imagesof the health of brain tissue; and (4) catheter angiogram, in which aguide catheter (e.g., having a length of about 80 cm to about 95 cm andan outer diameter of about 5 Fr to about 9 Fr (about 1.67 mm to about 3mm)) is routed from a femoral artery to a carotid or vertebral artery,then dye comprising iodine (e.g., iohexyl, iodixanol, etc.) is injectedfor direct imaging of the clot site, which is generally considered themost accurate of these four methods. Other measurement methods are alsopossible.

When using catheter angiogram for peripheral (e.g., leg) blockages, theguide catheter may be routed from the non-affected leg into the affectedleg (e.g., contrafemoral access), which allows the puncture to be in thedirection of the head so that blood flow can heal any dissection of thevessel. In some embodiments, the guide catheter of the catheterangiogram can be used for a treatment procedure, providing a generalcontinuity between diagnosis and treatment.

Clots in neurovasculature are generally between about 5 mm and about 55mm, although other clot lengths are also possible. Clots in peripheral(e.g., leg) vessels are generally between about 25 mm and about 90 mm,although other clot lengths are also possible.

After measurement, certain criteria can be used to determine whether aclot is a candidate for removal, such as the last time the patient wasseen acting normal (e.g., removal candidate if less than 12 hours ago),the National Institutes of Health (NIH) stroke scale (e.g., removalcandidate if greater than 10), imaging shows that a large vessel isblocked (e.g., removal candidate if large vessel blocked, which couldaffect many branch vessels), and/or imaging shows a small area of lossof tissue and/or a large area of tissue that can be salvaged. A clotthat is a candidate for removal can then be removed.

The femoral artery can act as a percutaneous entry point. As describedabove with respect to the catheter angiogram, for removal of aneurovascular clot, either leg can be used because both point towardsthe head, and, for removal of a peripheral clot, the non-affected legcan be used. A guide catheter is partially inserted into the entrypoint. In some embodiments, the guide catheter may have a length betweenabout 80 cm and about 95 cm, an inner diameter between about 5 Fr andabout 9 Fr (between about 1.67 mm and about 3 mm), and an outer diameterbetween about 6 Fr and about 10 Fr (between about 2 mm and about 3.3mm). A tapered dilator may extend about 1 inch to about 1.5 inches(approx. 2.5 cm to about 3.8 cm) out of the distal end of the guidecatheter for easier navigation.

A first steerable guidewire (e.g., having a length between about 150 cmand about 180 cm) is inserted into the guide catheter and the dilator,extending some distance (e.g., about 2 inches (approx. 5 cm) out of thedistal end of the dilator. The steerable guidewire can be advanced andsteered for some distance, followed by advancement of the guide catheterand dilator over the guidewire. The guidewire and the guide catheter canbe sequentially advanced until the desired point in the vasculature(e.g., the descending aorta). The dilator and guidewire are removed, butthe guide catheter is left in place. The desired point of thevasculature where advancement ceases may be the point where furtheradvancement of the dilator could perforate the vasculature.

A diagnostic catheter (e.g., having a length between about 100 cm andabout 125 cm (e.g., about 10 cm to about 20 cm longer than the guidecatheter)) having an outer diameter smaller than the inner diameter ofthe guide catheter (e.g., about 5 Fr (about 1.67 mm) when the guidecatheter has an inner diameter of about 5 Fr and about 9 Fr (betweenabout 1.67 mm and about 3 mm)) and an inner diameter that can accept asteerable guidewire (e.g., a guidewire having a diameter of about 0.035inches (approx. 0.9 mm)) (e.g., between about 3 Fr (about 1 mm) andabout 4 Fr (about 1.33 mm)) is then inserted into the guide catheter.

A second steerable guidewire (e.g., having a length between about 150 cmand about 180 cm), which may be the same as the first steerableguidewire or a different steerable guidewire, is inserted into thediagnostic catheter, extending some distance (e.g., about 2 inches(approx. 5 cm) out of the distal end of the diagnostic catheter. Thesteerable guidewire can be advanced and steered for some distance,followed by advancement of the diagnostic catheter over the guidewire.The guidewire and the diagnostic catheter can be sequentially advanceduntil the desired point in the vasculature (e.g., a carotid artery, avertebral artery), which may be about three inches (e.g., about 7.6 cm)distal to the distal end of the guide catheter. The dilator andguidewire are removed, but the guide catheter is left in place. Theguide catheter is then advanced over the diagnostic catheter to adesired position (e.g., slightly proximal to the distal end of thediagnostic catheter). The diagnostic catheter and guidewire are removed,but the guide catheter is again left in place. The guide catheter mayremain in this location for substantially the remainder of theprocedure.

FIG. 27A is a schematic diagram of a guide catheter 502 proximal to athrombus (e.g., clot) 500 in vasculature (e.g., the thrombus 500 in theright middle cerebral artery and the guide catheter 502 in the rightinternal carotid artery), for example having been routed to thatposition as described above. The thrombus 500 may have been noted duringangiography with the guide catheter 502 or another catheter (e.g., ashuttle or a balloon guide catheter), for example in the right internalcarotid artery. A catheter angiogram may be performed using the guidecatheter 502 after positioning the guide catheter 502.

In some embodiments, the guide catheter 502 may have a length betweenabout 45 cm and about 125 cm, between about 45 cm and about 80 cm (e.g.,about 55 cm) (e.g., for use in peripheral vasculature), between about 80cm and about 100 cm (e.g., about 100 cm) (e.g., for use in coronaryvasculature), between about 80 cm and about 125 cm (e.g., about 95 cm)(e.g., for use in neurovasculature). The guide catheter 502 may have awall thickness between about 0.002 inches (approx. 0.05 mm) and about0.04 inches (approx. 1 mm), which can allow for incorporating theproximal portion 200 within the walls of the guide catheter 502. Theguide catheter 502 may comprise a biomedical polymer, for examplesilicone, polyurethane (e.g., Polyslix, available from Duke Extrusion ofSanta Cruz, Calif.), polyethylene (e.g., Rexell®, available fromHuntsman) including low density polyethylene (LDPE), linear low densitypolyethylene (LLDPE), medium density polyethylene (MDPE), and highdensity polyethylene (HDPE), fluoropolymers such as fluorinated ethylenepropylene, PFA, MFA, PVDF, THV, ETFE, PCTFE, ECTFE (e.g., Teflon® FEP,available from DuPont), polypropylene, polyesters including polyethyleneterephthalate (PET), PBT, PETG (e.g., Hytrel®, available from DuPont),PTFE, combination polymer compounds such as thermoplastic polyurethanesand polyether block amides (e.g., Propell™, available from FosterCorporation of Putnam, Conn.), polyether block amides (e.g. Pebax®,available from Arkema of Colombes, France, PebaSlix, available from DukeExtrusion of Santa Cruz, Calif.), polyether soft blocks coupled withpolyester hard blocks vinyls such as PVC, PVDC, polyimides (e.g.,polyimides available from MicroLumen of Oldsmar, Fla.), polyamides(e.g., Durethan, available from Bayer, Nylon 12, available from DukeExtrusion of Santa Cruz, Calif.), polycarbonate (e.g., Corethane™,available from Corvita Corp. of Miami, Fla.), styrenics such as PS, SAN,ABS, and HIPS, acetals such as copolymers or homopolymers, hightemperature performance polymers such as PEEK, PES, PPS, PSU, LCP,combinations thereof, and the like.

The guide catheter 502 may comprise a hypotube (e.g., an uncut hypotubeand/or a hypotube cut with a plurality of interspersed offset patternsas described herein) and/or a plurality of filaments (e.g., woven,knitted, spiraled, etc.) as reinforcement, for example in combinationwith a polymer inward and/or outward thereof. As described herein,certain cut patterns may inhibit pinching to such a degree that polymermay be omitted. In some embodiments, the guide catheter 502 may includea long sheath, a shuttle, and/or a balloon guide catheter.

In some embodiments, the guide catheter 502 comprises a hypotubeincluding a cut patter, for example as described herein with respect tothe proximal portion 200 and catheters comprising the proximal portion200, for example to inherit the maneuverability advantages that may beprovided by the proximal portion 200 (e.g., to facilitate proximalsupport and distal flexibility). In some embodiments, the guide catheter502 comprises a parameter (e.g., slot pitch) that varies from proximalto distal. For example, the pitch between slots and/or windings of aspiral may vary, from the distal end to the proximal end, as follows:about 0.005 inches (approx. 0.13 mm), about 0.01 inches (approx. 0.25mm), about 0.02 inches (approx. 0.51 mm), about 0.04 inches (approx. 1mm), about 0.08 inches (approx. 2 mm), and about 0.16 inches (approx. 4mm). For another example, the pitch between slots and/or windings of aspiral may vary, from the distal end to the proximal end, as follows:about 0.005 inches (approx. 0.13 mm) for the distal-most about 20%,about 0.01 inches (approx. 0.25 mm) for the next about 15%, about 0.02inches (approx. 0.51 mm) for the next about 15%, about 0.04 inches(approx. 1 mm) for the next about 15%, about 0.08 inches (approx. 2 mm)for the next about 15%, and about 0.16 inches (approx. 4 mm) for thenext (or proximal-most) about 20%.

The guide catheter 502 may comprise a radiopaque marker (e.g., aradiopaque marker band as described herein) at a distal end and/or atregular intervals (e.g., between about 0.1 mm and about 50 mm, betweenabout 0.5 mm and about 1 mm, between about 1 mm and about 2 mm, betweenabout 2 mm and about 3 mm, between about 3 mm and about 4 mm, betweenabout 4 mm and about 5 mm, between about 5 mm and about 8 mm, betweenabout 8 mm and about 10 mm, between about 10 mm and about 12 mm, betweenabout 12 mm and about 15 mm, between about 15 mm and about 25 mm,between about 25 mm and about 35 mm, between about 35 mm and about 50 mmapart, including overlapping ranges thereof), which can help tovisualize the guide catheter 502 and assist in measuring clot length orvessel diameter, or lesion length or by serving as a surrogate markerfor a measurement tool.

FIG. 27B is a schematic diagram of a microwire 506 distal to a thrombus(e.g., clot) 500 in vasculature and a microcatheter 504 over themicrowire 506. FIG. 27C is an expanded view of FIG. 27B in the area ofthe thrombus 500. A microcatheter 504 having an outer diameter smallerthan the inner diameter of the guide catheter 502 and an inner diameterthat can accept a steerable microwire 506 (e.g., a guidewire having adiameter of about 0.014 inches (approx. 0.36 mm)) (e.g., between about0.0165 inches (approx. 0.42 mm) and about 0.017 inches (approx. 0.43mm)) is then inserted into the guide catheter 502. Microcatheters usedfor other thrombectomy devices generally have in internal diameter of0.021 inches (approx. 0.53 mm), although other inner diameters are alsopossible (e.g., about 0.014 inches (approx. 0.36 mm) about 0.017 inches(approx. 0.43 mm), about 0.027 inches (approx. 0.69 mm)). Themicrocatheter 504 may have a wall thickness between about 0.00075 inches(approx. 0.02 mm) and about 0.04 inches (approx. 1 mm), which can allowfor incorporating the proximal portion 200 within the walls of themicrocatheter 504. A smaller diameter microcatheter 504 can be easierand/or faster to route over a microwire 506, which can reduce proceduretime. The microcatheter 504 may have a length between about 80 cm andabout 210 cm, between about 80 cm and about 120 cm (e.g., for use inperipheral vasculature), between about 120 cm and about 150 cm (e.g.,for use in coronary vasculature), between about 150 cm and about 210 cm(e.g., about 180 cm) (e.g., for use in neurovasculature).

The microcatheter 504 may comprise a biomedical polymer, for examplesilicone, polyurethane (e.g., Polyslix, available from Duke Extrusion ofSanta Cruz, Calif.), polyethylene (e.g., Rexell®, available fromHuntsman) including low density polyethylene (LDPE), linear low densitypolyethylene (LLDPE), medium density polyethylene (MDPE), and highdensity polyethylene (HDPE), fluoropolymers such as fluorinated ethylenepropylene, PFA, MFA, PVDF, THV, ETFE, PCTFE, ECTFE (e.g., Teflon® FEP,available from DuPont), polypropylene, polyesters including polyethyleneterephthalate (PET), PBT, PETG (e.g., Hytrel®, available from DuPont),PTFE, combination polymer compounds such as thermoplastic polyurethanesand polyether block amides (e.g., Propell™, available from FosterCorporation of Putnam, Conn.), polyether block amides (e.g. Pebax®,available from Arkema of Colombes, France, PebaSlix, available from DukeExtrusion of Santa Cruz, Calif.), polyether soft blocks coupled withpolyester hard blocks vinyls such as PVC, PVDC, polyimides (e.g.,polyimides available from MicroLumen of Oldsmar, Fla.), polyamides(e.g., Durethan, available from Bayer, Nylon 12, available from DukeExtrusion of Santa Cruz, Calif.), polycarbonate (e.g., Corethane™,available from Corvita Corp. of Miami, Fla.), styrenics such as PS, SAN,ABS, and HIPS, acetals such as copolymers or homopolymers, hightemperature performance polymers such as PEEK, PES, PPS, PSU, LCP,combinations thereof, and the like.

The microcatheter 504 may comprise a hypotube (e.g., an uncut hypotubeand/or a hypotube cut with a plurality of interspersed offset patternsas described herein) and/or a plurality of filaments (e.g., woven,knitted, spiraled, etc.) as reinforcement, for example in combinationwith a polymer inward and/or outward thereof. As described herein,certain cut patterns may inhibit pinching to such a degree that polymermay be omitted.

The microcatheter 504 may comprise a radiopaque marker (e.g., aradiopaque marker band as described herein) at a distal end and/or atregular intervals (e.g., between about 0.1 mm and about 50 mm, betweenabout 0.5 mm and about 1 mm, between about 1 mm and about 2 mm, betweenabout 2 mm and about 3 mm, between about 3 mm and about 4 mm, betweenabout 4 mm and about 5 mm, between about 5 mm and about 8 mm, betweenabout 8 mm and about 10 mm, between about 10 mm and about 12 mm, betweenabout 12 mm and about 15 mm, between about 15 mm and about 25 mm,between about 25 mm and about 35 mm, between about 35 mm and about 50 mmapart, including overlapping ranges thereof), which can help tovisualize the microcatheter 504 and assist in measuring clot length byserving as a surrogate marker for a measurement tool.

A steerable microwire 506 (e.g., having an outer diameter of about 0.014inches (approx. 0.36 mm) is inserted into the microcatheter 504,extending some distance (e.g., about 2 cm to about 4 cm) out of thedistal end of the microcatheter 504. The microwire 506 can be advancedand steered for some distance, followed by advancement of themicrocatheter 504 over the microwire 506. The microwire 506 and themicrocatheter 504 can be sequentially advanced until the desired pointin the vasculature (e.g., distal to the clot by about 0.5 mm to about 5mm). FIG. 27D is a schematic diagram of a microcatheter 504 distal to athrombus (e.g., clot) 500 in vasculature (e.g., the thrombus 500 in theright middle cerebral artery).

In some embodiments, the microwire 506 can cross the clot, for exampleby slicing through a middle part of the clot. If the clot is hard or isdifficult for the microwire 506 to traverse, the microwire 506 may beused as a launching pad to guide advance the microcatheter 504 past theclot and the microwire 506. In certain such embodiments, themicrocatheter 504 does not traverse the clot. In some embodiments, themicrocatheter 504 may have a distal end configured to traverse hardclots (e.g., a generally rigid cylinder). In some embodiments, forexample in which the lesion is calcified (e.g., heavily calcified), athrombolytic and/or crossing device may aid the microwire 506 and/ormicrocatheter 504 across the clot.

FIG. 27D is a schematic diagram of a microcatheter 504 distal to athrombus (e.g., clot) 500 in vasculature. Once the microcatheter 504 isdistal to the thrombus 500, the microwire 506 is removed or retracted,and the microcatheter 504 is left in place, with the distal end of themicrocatheter 504 distal to the distal end of the thrombus 500.

A dye comprising iodine (e.g., iohexyl, iodixanol, etc.) can be injectedinto the microcatheter 504 and/or between the guide catheter and themicrocatheter 504, for example to help to define the proximal and distalends of the thrombus 500. The length and diameter of the thrombus 500can be measured, from which the volume of the thrombus 500, or the clotburden, can be calculated.

In some systems using a microcatheter (e.g., a microcatheter having ininternal diameter of 0.021 inches (approx. 0.53 mm)), a thrombectomydevice, for example being laser cut for that purpose or an adaptedlaser-cut stent, having a set length is advanced to remove the clotpiecemeal. For example, if the length of the thrombectomy device is 5 mmand the length of the clot is 15 mm, at least three removal proceduresare needed. The thrombectomy device generally must be fully removed fromthe body to clear the captured clot piece, and removal of each clotpiece can take up to about forty minutes. For clots in neurovasculature,about 1,900,000 brain cells die per minute. Thus, for a three-partremoval process where each removal takes forty minutes, about228,000,000 brain cells could die. If the diameter of the vasculaturevaries, or if one thrombectomy device is otherwise not suitable forremoving each piece of the clot, multiple thrombectomy devices may beused, which can greatly increase the cost of the procedure. Users maysometimes opt to remove less than the full clot to reduce procedure timeand/or the number of thrombectomy devices used, or in some cases maychoose to not retrieve a clot at all due to knowledge that multipleremoval iterations and/or thrombectomy devices will be needed. Suchpractices can produce unacceptable results for patients, doctors, andhospitals.

FIG. 27E is a schematic diagram illustrating an example embodiment ofthe distal portion 100 of a vascular treatment device being introducedinto the hub 590 of a microcatheter 504 through an introducer sheath540. Referring again to the devices 10, 20, 30, 40 described herein, theintroducer sheath 540 is placed into a funnel-shaped proximal end 590 ofthe microcatheter 504, which is in the guide catheter 502. In someembodiments, the proximal end 590 of the microcatheter 504 is placedinto the proximal end of a Y-connector 592 including a valve (e.g., arotating hemostatic valve) to allow flushing (e.g., with saline) before,during, and/or after advancing the device 10, 20, 30, 40. The distal endof the Y-connector 592 may be attached to the proximal end of the guidecatheter 502. The proximal portion 200 is pushed to advance the device10, 20, 30, 40 through the microcatheter 504, with the distal portion100 in the constrained state. The introducer sheath 540 can inhibitkinking of the proximal portion 200 during this insertion. Theintroducer sheath 540 can be retracted relative to the proximal portion200 to unsheathe the proximal portion 200. In some embodiments, aradiopaque marker (e.g., the radiopaque marker bands 25, 1720 describedherein) can be used to track the progress of the advancement of thedevice 10, 20, 30, 40 and/or portions thereof. For example, in someembodiments, the microcatheter 504 may include a radiopaque marker(e.g., marker band) at a distal tip, and the location of the radiopaquemarker of the device 10, 20, 30, 40 can be compared thereto.

In some embodiments, the microcatheter 504 is reinforced with theproximal portion 200, for example to inherit the maneuverabilityadvantages of the proximal portion 200 (e.g., to facilitate proximalsupport and distal flexibility). In some embodiments, the microcatheter504 comprises a parameter (e.g., slot pitch) that varies from proximalto distal. For example, the pitch between slots and/or windings of aspiral may vary, from the distal end to the proximal end, as follows:about 0.005 inches (approx. 0.13 mm), about 0.01 inches (approx. 0.25mm), about 0.02 inches (approx. 0.51 mm), about 0.04 inches (approx. 1mm), about 0.08 inches (approx. 2 mm), and about 0.16 inches (approx. 4mm). For another example, the pitch between slots and/or windings of aspiral may vary, from the distal end to the proximal end, as follows:about 0.005 inches (approx. 0.13 mm) for the distal-most 20%, about 0.01inches (approx. 0.25 mm) for the next 15%, about 0.02 inches (approx.0.51 mm) for the next 15%, about 0.04 inches (approx. 1 mm) for the next15%, about 0.08 inches (approx. 2 mm) for the next 15%, and about 0.16inches (approx. 4 mm) for the next (or proximal-most) 20%.

FIG. 27F is a schematic partial cross-sectional view of an exampleembodiment of a distal portion 100 of a vascular treatment device withinan introducer sheath 540. The introducer sheath includes a tapereddistal end 545 configured to mate with the funnel-shaped portion of theproximal end 590 of a microcatheter 504. When the distal portion 100 iswithin the introducer sheath 540, and when the distal portion 100 iswithin the microcatheter 504, the distal portion 100 is in a collapsedstate (e.g., a tubular state without bulbs).

The device 10, 20, 30, 40 is advanced until the distal end of the distalportion 100 is proximate to the distal end of the microcatheter 504,which is distal to the distal end of the thrombus 500. The microcatheter504 is then retracted (e.g., unsleeved, unsheathed) while holding theproximal portion 200 still so that the longitudinal position of thedevice 10, 20, 30, 40 is maintained. FIG. 27G is a schematic diagram ofpart of a distal portion 100 of a vascular treatment device 10, 20, 30,40 being deployed distal to a thrombus (e.g., clot) 500 in vasculature.The retraction of the microcatheter 504 exposes the distal portion 100,from the distal end back, which allows the exposed sections of thedistal portion 100 to self-expand. For example, the distal neck 65 andthe distal-most bulb can expand.

In some embodiments, self-expansion of the exposed sections of thedistal portion 100 at least partially because the distal portion 100includes at least some super-elastic filaments that can, for example,self-expand due to stress-induced martensite (SIM) without anyparticular change in temperature. Super-elastic materials can expandsubstantially instantaneously from a collapsed configuration to anexpanded configuration when the unsheathed. In some embodiments,self-expansion of the exposed sections of the distal portion 100 is atleast partially because the distal portion 100 includes at least someshape memory filaments that can, for example, self-expand due toheat-activated austenitic transformation (e.g., upon a particular changein temperature such as greater than room temperature (about 25° C.),about body temperature (approx. 37° C.), etc.). Shape-memory materialscan expand slowly from a collapsed configuration to an expandedconfiguration when unsheathed upon contact with warm fluid (e.g., bloodat body temperature, warm saline).

In some embodiments, the shape memory effect of the shape memoryfilaments can be one-way (e.g., a stress-induced change in shape returnsto a baseline shape upon heating, while there is no further change uponcooling). The material remembers one shape with the one-way shape memoryeffect, the shape at high temperature. In some embodiments, the shapememory effect of the shape memory filaments can be two-way (e.g., astress-induced change in shape returns close to baseline shape uponheating, while a second shape can be achieved upon cooling). Thematerial remembers two shapes with the two-way shape memory effect, afirst shape at high temperature and a second shape at low temperature.

In some embodiments, the length of the retraction of the microcatheter504, and the amount of the distal portion 100 exposed, can be related tothe length of the thrombus 500, for example as measured as describedabove. For example, the microcatheter 504 can be retracted until a bulbis proximal to the proximal end of the thrombus 500.

The length of the distal portion 100 and/or number of bulbs that can beunsheathed to treat a thrombus (e.g., clot) 500 is customizable for eachthrombus 500. For example, if using the distal portion 1100 describedabove to treat a 10 mm thrombus 500, the distal-most bulb 1112 could bedeployed distal to the thrombus 500, then the next two bulbs 1112, thenthe distal bulb 1114 could be deployed proximal to the thrombus 500,while the other two bulbs 1114 and the bulbs 1116, 1118 remain in themicrocatheter 504. For another example, if using the distal portion 1100described above to treat a 40 mm thrombus 500, the distal-most bulb 1112could be deployed distal to the thrombus 500, then the next five bulbs1112, 1114, 1116, then the distal bulb 1118 could be deployed proximalto the thrombus 500, while the proximal-most bulb 1118 remains in themicrocatheter 504. Such customizability can advantageously improve atleast one of the drawbacks to treating clots 500 with other thrombectomydevices described above (e.g., treatment time, multiplied costs, userreluctance, etc.).

In some embodiments, if one bulb cannot fully entrap the thrombus (e.g.,clot) 500, another bulb (whether the same or different in size and/orshape) and/or a plurality of blubs can entrap the thrombus 500. In someembodiments, the undulations (e.g., the hills and valleys created by thebulbs and/or at the micro level by the braiding pattern) facilitatethrombus 500 entrapment. Undulating and/or dual undulation may enhancescraping of sidewalls and thrombus 500 entrapment. The thrombus 500,once entrapped or captured by the bulbs, can be removed as thethrombectomy device 10, 20, 30, 40 is removed from the subject.Particles that break off from the clot (e.g., emboli) can be captured byat least one bulb (including, but not limited to, the distal-mostbulb(s)).

The procedures described herein are not limited to deploying parts ofthe distal portion 100 based on an initial thrombus (e.g., clot) sizemeasurement. In some embodiments, the length of the thrombus 500 is notmeasured. In some embodiments, the number of bulbs deployed can helpmeasure the length of the thrombus 500 as the procedure is occurring(e.g., using radiopaque markers, using radiopaque strand helixcrossings, etc.).

As the distal portion 100 expands radially outwardly, some parts of thethrombus (e.g., clot) 500 are pushed towards the vessel sidewalls andsome parts of the thrombus 500 are trapped between bulbs of the distalportion 100. Some parts of the thrombus 500 may also be trapped betweenfilament crossings of the distal portion 100. FIG. 27H is a schematicdiagram of a distal portion 100 of a vascular treatment device beingdeployed across a thrombus 500 in vasculature.

FIG. 27I-1 is a schematic diagram illustrating an example embodiment ofthe distal portion 100 of a vascular treatment device being used inconjunction with thrombus aspiration. In some embodiments, referringagain to FIG. 27A, a distal access microcatheter 530 and a microcatheter504 inserted inside the distal access microcatheter 530 may be advancedover a steerable microwire 506 and through a guide catheter 502positioned proximal to the thrombus 500. A steerable microwire 506(e.g., having an outer diameter of about 0.014 inches (approx. 0.36 mm)is inserted into the microcatheter 504, extending some distance (e.g.,about 2 cm to about 4 cm) out of the distal end of the microcatheter504. The microwire 506 can be advanced and steered for some distance,followed by advancement of the microcatheter 504 over the microwire 506,followed by advancement of the distal access microcatheter 530 over themicrocatheter 504. The microwire 506, the microcatheter 504, and thedistal access microcatheter 530 can be sequentially advanced until thedesired point in the vasculature (e.g., distal to the clot or lesion byabout 0.5 mm to about 5 mm for the microcatheter 504, and proximal tothe clot or lesion by about 0.5 mm to about 15 cm for the distal accessmicrocatheter 530). FIG. 27I-1 schematically shows the distal accessmicrocatheter 530 proximal to a thrombus (e.g., clot) 500 in vasculature(e.g., in the right middle cerebral artery). The microcatheter 504 isalso proximal to the thrombus 500 and the distal portion 100 of thedevice 10, 20, 30 or 40 has been deployed across the entire length ofthe thrombus 500.

The distal access microcatheter 530 may provide proximal support to themicrocatheter 504 and/or for aspiration. In some embodiments, the distalend of the distal access microcatheter 530 includes a balloon, and thedistal access microcatheter 530 may be used like a balloon guidecatheter, for example to provide temporary flow arrest and/or as anadjunct device during thrombus aspiration. In some embodiments, thedistal access microcatheter 530 may have a length between about 45 cmand about 150 cm, between about 45 cm and about 80 cm (e.g., about 75cm) (e.g., for use in peripheral vasculature), between about 80 cm andabout 100 cm (e.g., about 100 cm) (e.g., for use in coronaryvasculature), between about 80 cm and about 150 cm (e.g., about 125 cm)(e.g., for use in neurovasculature). The distal access microcatheter 530may have a wall thickness between about 0.00075 inches (approx. 0.02 mm)and about 0.04 inches (approx. 1 mm), which can allow for incorporatingthe proximal portion 200 within the walls of the distal accessmicrocatheter 530. In some embodiments, the distal access microcatheter530 may have an inner diameter between about 4 Fr (about 1.33 mm) andabout 7 Fr (about 2.33 mm) for example, about 5 Fr (about 1.67 mm), andan outer diameter between about 5 Fr (about 1.67 mm) and about 9 Fr(about 3 mm) for example, about 6 Fr (about 2 mm).

The distal access microcatheter 530 may comprise a biomedical polymer,for example silicone, polyurethane (e.g., Polyslix, available from DukeExtrusion of Santa Cruz, Calif.), polyethylene (e.g., Rexell®, availablefrom Huntsman) including low density polyethylene (LDPE), linear lowdensity polyethylene (LLDPE), medium density polyethylene (MDPE), andhigh density polyethylene (HDPE), fluoropolymers such as fluorinatedethylene propylene, PFA, MFA, PVDF, THV, ETFE, PCTFE, ECTFE (e.g.,Teflon® FEP, available from DuPont), polypropylene, polyesters includingpolyethylene terephthalate (PET), PBT, PETG (e.g., Hytrel®, availablefrom DuPont), PTFE, combination polymer compounds such as thermoplasticpolyurethanes and polyether block amides (e.g., Propell™, available fromFoster Corporation of Putnam, Conn.), polyether block amides (e.g.Pebax®, available from Arkema of Colombes, France, PebaSlix, availablefrom Duke Extrusion of Santa Cruz, Calif.), polyether soft blockscoupled with polyester hard blocks vinyls such as PVC, PVDC, polyimides(e.g., polyimides available from MicroLumen of Oldsmar, Fla.),polyamides (e.g., Durethan, available from Bayer, Nylon 12, availablefrom Duke Extrusion of Santa Cruz, Calif.), polycarbonate (e.g.,Corethane™, available from Corvita Corp. of Miami, Fla.), styrenics suchas PS, SAN, ABS, and HIPS, acetals such as copolymers or homopolymers,high temperature performance polymers such as PEEK, PES, PPS, PSU, LCP,combinations thereof, and the like.

The distal access microcatheter 530 may comprise a hypotube (e.g., anuncut hypotube and/or a hypotube cut with a plurality of interspersedoffset patterns as described herein) and/or a plurality of filaments(e.g., woven, knitted, spiraled, etc.) as reinforcement, for example incombination with a polymer inward and/or outward thereof. As describedherein, certain cut patterns may inhibit pinching to such a degree thatpolymer may be omitted. In some embodiments, the distal accessmicrocatheter 530 may provide an access device for proximal supportand/or a thrombus aspiration device.

In some embodiments, the distal access microcatheter 530 is reinforcedwith the proximal portion 200, for example to inherit themaneuverability advantages of the proximal portion 200 (e.g., tofacilitate proximal support and distal flexibility). In someembodiments, the distal access microcatheter 530 comprises a parameter(e.g., slot pitch) that varies from proximal to distal. For example, thepitch between slots and/or windings of a spiral may vary, from thedistal end to the proximal end, as follows: about 0.005 inches (approx.0.13 mm), about 0.01 inches (approx. 0.25 mm), about 0.02 inches(approx. 0.51 mm), about 0.04 inches (approx. 1 mm), about 0.08 inches(approx. 2 mm), and about 0.16 inches (approx. 4 mm). For anotherexample, the pitch between slots and/or windings of a spiral may vary,from the distal end to the proximal end, as follows: about 0.005 inches(approx. 0.13 mm) for the distal-most about 20%, about 0.01 inches(approx. 0.25 mm) for the next about 15%, about 0.02 inches (approx.0.51 mm) for the next about 15%, about 0.04 inches (approx. 1 mm) forthe next about 15%, about 0.08 inches (approx. 2 mm) for the next about15%, and about 0.16 inches (approx. 4 mm) for the next (orproximal-most) about 20%.

The distal access microcatheter 530 may comprise a radiopaque marker(e.g., a radiopaque marker band as described herein) at a distal endand/or at regular intervals (e.g., between about 0.1 mm and about 50 mm,between about 0.5 mm and about 1 mm, between about 1 mm and about 2 mm,between about 2 mm and about 3 mm, between about 3 mm and about 4 mm,between about 4 mm and about 5 mm, between about 5 mm and about 8 mm,between about 8 mm and about 10 mm, between about 10 mm and about 12 mm,between about 12 mm and about 15 mm, between about 15 mm and about 25mm, between about 25 mm and about 35 mm, between about 35 mm and about50 mm apart, including overlapping ranges thereof), which can help anoperator of the distal access microcatheter 530 visualize the distalaccess microcatheter 530, which can assist in measuring clot length,vessel diameter, and/or lesion length, and/or which can serve as asurrogate marker for a measurement tool.

In some embodiments, thrombus aspiration may be performed through themicrocatheter 504, the distal access microcatheter 530, and/or the guidecatheter 502 depending on the extent of the clot burden. In someembodiments, thrombus aspiration may be performed through the catheteror microcatheter that is closest in proximity to the thrombus (e.g.,clot) 500. In some embodiments, thrombus aspiration may be performedusing flow arrest, wherein a balloon, such as part of a balloon guidecatheter 502 or a balloon as part of a distal access microcatheter 530,is inflated proximal to the thrombus 500 and anterograde forward flowproximal to the thrombus 500 is temporarily stopped while thrombusaspiration is performed. In some embodiments, thrombus aspiration may beperformed without any balloon inflation or temporary flow arrest.

In some embodiments, thrombus aspiration may be performed using manualnegative intermittent suction (e.g., provided by a syringe) or using anautomated negative suction device (e.g., provided by a vacuum pump). Thesuction device may be connected through suction tubing with a luer lockto the hub 590 of the microcatheter 504, the distal access microcatheter530, and/or the guide catheter 502, or through a stop cock attached tothe side port of a Y-connector 592 connected to the hub 590 of themicrocatheter 504, the distal access microcatheter 530, the guidecatheter 502, and/or a balloon guide catheter 502. The suction tubingmay have a length that ranges from about 15 cm to about 150 cm (e.g.,about 90 cm). The suction tubing may comprise a biomedical polymer, forexample those described herein.

If the inner lumen of the microcatheter 504 or guide catheter 502 issubstantially uniform, then the cross sectional area of themicrocatheter 504 or guide catheter 502 can be considered a cylinderhaving a substantially uniform cross-sectional area k=πr² and a volumeV=πr²L. The volume of dead space within the lumen of the microcatheter504 or the guide catheter 502 prior to starting suction may beconsidered to be a cylinder (V₀=πr²L₀) with an initial suction pressureP₀. The volume of the dead space within the lumen of the microcatheter504 or the guide catheter 502 after suction may also be considered to bea cylinder (V₁=πr²L₁) with a suction pressure P₁. If the suction processis considered an isothermal process, then the suction pressure can becalculated using Equations 6-8:P ₀ V ₀ =P ₁ V ₁  (Eq. 6)P ₀ k ₀ L ₀ =P ₁ k ₁ L ₁  (Eq. 7)P ₀ r ₀ ² L ₀ =P ₁ r ₁ ² L ₁  (Eq. 8)

If the inner lumen of the microcatheter 504 or the guide catheter 502 issubstantially uniform, then the amount of negative suction pressure isdirectly proportional to the length of the negative suction columnwithin the microcatheter 504 or the guide catheter 502. The change insuction pressure (ΔP) can be calculated using Equation 9:ΔPαΔL  (Eq. 9)

If the inner lumen diameter or cross sectional area of a catheter issubstantially uniform, then an increase in catheter length increasespressure to achieve desired suction. Higher suction pressures forthrombus aspiration in substantially uniform catheters can have clinicalimplications, such as: (1) higher suction pressures can result incollapse of blood vessel walls; (2) higher suction pressures can resultin collapse or kinking of polymeric microcatheters or catheters; and/or(3) higher suction pressures can have safety implications on theendothelial inner wall of the blood vessels and increase the risk ofvessel injury, partial or complete vessel tears, and/or vessel rupture.

The cross sectional area of the distal access microcatheter 530, themicrocatheter 504, or the guide catheter 502 may not substantiallyuniform across the inner lumen (e.g., having a tapered configurationschematically similar to the inlet device 10300 illustrated in FIG.17N). Referring again to FIG. 17N, in some embodiments, themicrocatheter 504, the distal access microcatheter 530, or the guidecatheter 502 may include a gradual tapering of the inner lumen diametersor cross sectional areas from proximal to distal, for example asdescribed with respect to the tubes 10305, 10310, 10315, 10320, in whichthe smaller diameter tubing 10305 would be at the distal end proximateto the thrombus (e.g., clot) 500, and the larger diameter tubing 10320would be at the proximal end connected to the suction device. Thedirection of flow of blood during thrombus aspiration would be in thedirection opposite to the arrows illustrated in FIG. 17N such that thethrombus 500 is aspirated from the distal end towards the proximal endof the distal access microcatheter 530, the distal end of themicrocatheter 504, or the guide catheter 502.

Still with reference to FIG. 17N, a proximal segment 10320 of themicrocatheter 504, the distal access microcatheter 530, or the guidecatheter 502 may be at an adjustable height h₄, has a pressure P₄, andhas a fluid velocity v₄. Blood entering the proximal portion 200 at adistal segment 10305 of the microcatheter 504, the distal accessmicrocatheter 530, or the guide catheter 502 is at a height h₁, has apressure P₁, and has a fluid velocity v₁. As the sum of the kineticenergy per unit volume (½ρ_(b)v²), the potential energy per unit volume(ρ_(b)gh), and the pressure energy (P) remain the same, the density ofthe blood ρ_(b) and the acceleration due to gravity g (9.8 m/second²)remain constant, the fluid velocity v₄ entering the proximal portion 200at the distal end of the of the microcatheter 504, the distal accessmicrocatheter 530, or the guide catheter 502 can be calculated usingEquation 10:½ρv ₁ ²+ρ_(b) gh ₁ +P ₁=½ρ_(b) v ₄ ²+ρ_(b) gh ₄ +P ₄  (Eq. 10)or, rearranged, v ₄ =√[v ₁ ²+1960(h ₁ −h ₄)+2(P ₁ −P ₄)/ρ_(b)]

Since there is no fluid velocity at the distal end of the of themicrocatheter 504, the distal access microcatheter 530, or the guidecatheter 502 prior to suction being initiated (v₁=0) and the height ofthe proximal and distal ends of the of the microcatheter 504, the distalaccess microcatheter 530, or the guide catheter 502 (h₁=h₄), Equation 10may be reduced to Equation 11, or simplified by the relationship ofEquation 12:(P ₁ −P ₄)=½ρ_(b) v ₄ ²  (Eq. 11)or, rearranged, v ₄=√[2(P ₁ −P ₄)/ρ_(b)]ΔPαv ₄ ²  (Eq. 12)

In some embodiments, whenever the inner lumen diameter or crosssectional area is not substantially uniform (e.g., is tapered), then achange in suction pressure can result in a change in the square of thevelocity of blood, which can result in desired thrombus aspiration.Limited suction pressures for thrombus aspiration in microcatheters orcatheters with tapered inner lumens or cross sectional areas can haveclinical implications: such as: (1) limited suction pressures caninhibit collapse of blood vessel walls; (2) limited suction pressuresand/or presence of a laser cut hypotube for reinforcement can inhibitcollapse or kinking of polymeric microcatheters or catheters; and/or (3)limited suction pressures may have a gentle effect on the endothelialinner wall of the blood vessels and reduce the risk of vessel injury.

In some embodiments, suction during thrombus aspiration through asyringe may not be substantially uniform, but can have a “crescendosuction” pattern. FIG. 27I-2 is a table schematically illustratingexample embodiments of crescendo suction patterns 11800, 11805, 11810,11815, 11820 for aspiration (e.g., thrombus aspiration). Cycles ofcrescendo suction patterns 11800, 11805, 11810, 11815, 11820 maycomprise variable intensities of negative suction in a crescendo patternsuch as a small intensity negative suction pressure (S), a mediumintensity negative suction pressure (M), large intensity negativesuction pressure (L), and pauses or temporary stops to the negativesuction pressure, which are represented by a dot or period (.) in FIG.27I-2. The crescendo suction pattern 11800 comprises a small intensitynegative suction pressure (S) followed by a pause (.), which is repeatedthree more times (S.S.S.S.), then the pattern 11800 comprises a mediumintensity negative suction pressure (M) followed by a pause (.), whichis repeated three more times (M.M.M.M.), then the pattern 11800comprises a large intensity negative suction pressure (L) followed by apause (.), which is repeated three more times (L.L.L.L.). In someembodiments of thrombus aspiration, the crescendo suction pattern mayinclude the following components, combinations thereof, and the like:the crescendo suction pattern 11805 (SML.SML.SML.); the crescendosuction pattern 11810 (S.M.L.S.M.L); the crescendo suction pattern 11815(S.L.S.L.S.L.); and/or the crescendo suction pattern 11820(S.L.M.L.S.L.M.L.). The third column graphically illustrates thepatterns 11800, 11805, 11810, 11815, 11820 with the x-axis being timeand the y-axis being intensity of negative suction pressure. Thecrescendo suction patterns 11800, 11805, 11810, 11815, 11820 may beuseful in different clinical scenarios. For example, the crescendosuction pattern 11810, which includes several pauses or temporary stops,may be useful in thrombus aspiration of hard clots, for example becausethe gradual increase in intensity of negative suction pressure withfrequent pauses can assist agitation of the clot and/or facilitatethrombus aspiration. For another example, the crescendo suction pattern11805, which includes few pauses or temporary stops, may be useful inthrombus aspiration of soft clots, for example because the gradualincrease in intensity of negative suction pressure with few pauses canassist with suction of the soft clot and/or facilitate thrombusaspiration.

In some embodiments, the duration of the components of a crescendosuction pattern 11800, 11805, 11810, 11815, 11820 during thrombusaspiration may vary as follows: the duration of the small intensitynegative suction (S) ranges between about 1 second to about 30 seconds(e.g., about 5 seconds); the duration of the medium intensity negativesuction (M) ranges between about 1 second to about 30 seconds (e.g.,about 5 seconds); the duration of the large intensity negative suction(L) ranges between about 1 second to about 30 seconds (e.g., about 5seconds); and the pauses or temporary stops ranges between the durationof the small intensity negative suction (S) ranges between about 1second to about 15 seconds (e.g., about 5 seconds). The total durationof crescendo suction pattern including multiple repetitive cycles ofpatterns may range from between about 1 minute to about 15 minutes(e.g., about 5 minutes). Although some example durations are providedherein, some embodiments of the crescendo suction patterns 11800, 11805,11810, 11815, 11820 may include durations of the patterns in accordancewith the values provided above and/or durations that are about ±5%,about ±10%, about ±15%, or about ±20% of any such values andcombinations thereof, and the like. The crescendo suction patterns11800, 11805, 11810, 11815, 11820 may be considered to be uniform if thedurations of each of the components of the crescendo suction pattern aresubstantially similar, or may be considered variable if the durations ofat least one (e.g., some or all) of the components of the crescendosuction pattern are different.

In some embodiments, the intensity of the components of the crescendosuction pattern 11800, 11805, 11810, 11815, 11820 during thrombusaspiration may vary as follows: (1) the intensity of negative suctionpressure for the small intensity negative suction (S) ranges betweenabout 100 mm Hg (approx. 13 kN/m²) to about 350 mm Hg (approx. 47 kN/m²)(e.g., about 250 mm Hg (approx. 33 kN/m²)); (2) the intensity of themedium intensity negative suction (M) ranges between about 351 mm Hg(approx. 47 kN/m²) to about 550 mm Hg (approx. 73 kN/m²) (e.g., about500 mm Hg (approx. 67 kN/m²); and (3) the intensity of the largeintensity negative suction (L) ranges between about 551 mm Hg (approx.73 kN/m²) to about 760 mm Hg (approx. 1 atm; approx. 101 kN/m²) (e.g.,about 750 mm Hg (approx. 100 kN/m²). Although some example intensitiesare provided herein, some embodiments of the crescendo suction patterns11800, 11805, 11810, 11815, 11820 may include intensities of thenegative suction pressures in accordance with the values provided aboveand/or durations that are about ±5%, about ±10%, about ±15%, or about±20% of any such values and combinations thereof, and the like. Thecrescendo suction patterns 11800, 11805, 11810, 11815, 11820 may beconsidered to be uniform if the intensities of the negative suctionpressure of each of the components of the crescendo suction pattern aresubstantially similar, or may be considered variable if the intensitiesof at least one (e.g., some or all) of the components of the crescendosuction pattern are different.

In some embodiments, the suction tubing is connected to a disposablecanister and a peristaltic motor pump. In some embodiments, theperistaltic motor pump is controlled by power electronics to generatethe crescendo suction patterns 11800, 11805, 11810, 11815, 11820 with adesired intensity and/or duration of negative suction pressure. Thepower electronics may comprise an customized integrated circuit board oran integrated chip, and the crescendo suction patterns 11800, 11805,11810, 11815, 11820 can be stored in the power electronics. Theperistaltic motor pump includes a switch or external control panel forthe operator configured to allow the operator to choose from any of thecrescendo suction patterns 11800, 11805, 11810, 11815, 11820 during athrombus aspiration procedure.

In some embodiments, as the distal portion 100 expands radiallyoutwardly, parts of the vessel wall may slightly expand, the amount ofexpansion depending on, e.g., braid parameters, filament material,filament size, etc. Vessel expansion can create a channel to the sidesof the thrombus (e.g., clot) 500 to at least partially restore bloodflow even before removal of the thrombus 500. As described above, about1,900,000 brain cells die every minute without blood supply, so thebrain cells kept alive by this restoration could be significant. To theextent that current thrombectomy devices may also create a channel uponexpansion, such channel may only be along a portion of the thrombus 500such that the tissue distal thereto is still devoid of blood flow. Somecurrent thrombectomy (e.g., laser-cut) devices may also cause stress tovessel sidewalls because they are not size-sensitive, so such vesselexpansion could even lead to rupturing and/or causing distal debris. Bycontrast, some embodiments of the distal portions 100 described hereincan create a channel that is proportional to size of vessel, which isgentler and safer than size-blind expansion, and a distal bulb can trapdistal debris.

In some embodiments, after unsheathing part of the distal portion 100(e.g., enough so that a bulb is proximal to the proximal end of thethrombus 500), the device 10, 20, 30, 40 may optionally be torsionallyrasped in a rotational direction. Part of the proximal portion 200outside the subject is rotated by the user. The distal portion 100,coupled to the proximal portion 200, also rotates. In some embodiments,part of the distal portion 100 apposes the sidewalls of the vessel andresists rotation. The rotational forces are generally exerted fromproximal to distal along the length of the distal portion 100, so thedistal-most part apposing the sidewalls of the vessel are most likely torotate last. In some embodiments, a distal-most bulb of the distalportion 100 apposes the sidewalls of the vessel distal to the thrombus500. In certain such embodiments, the distal-most bulb of the distalportion 100 substantially maintains a rotational position until expandedparts of the distal portion 100 proximal to the distal-most bulb are atleast partially rotated. Rotation of the distal portion 100 entraps theclot and collects any debris. The distal portion 100 can rotationallyscrape the sidewalls of the vessel to remove portions of the clotattached to the endothelium wall, which can remove more thanfree-floating debris. The non-laser cut braided nature of the bulbs canfacilitate gentle entrapment of the clot without perforating the vessel.

As used herein, torsional rasping shall be given its ordinary meaningand shall include wringing and twisting. An incomplete analogy fortorsional rasping is wringing out a towel, where a person grabs one endof the towel with one hand and the opposite end of the towel with theother hand, and, while holding the first end still, rotates the secondend. The towel twists, generally shrinking in diameter, until physicalforces inhibit further rotation. Rather than ends of a towel, ends ofthe distal portion 100 are grasped, the distal end by apposing sidewallsand the proximal end by the proximal portion. FIG. 27J is a schematicdiagram of a distal portion 100 of a vascular treatment device beingtorsionally rasped. In FIG. 27J, the initial rotation of theproximal-most expanded bulbs of the distal portion 100 are shown. Theanalogy is incomplete because the towel does not inform clot entrapment.As described herein, the braided nature of the distal portion 100 cantrap the clot between undulations between the bulbs and/or undulationsof the woven wires. FIG. 27K is a schematic diagram of a distal portion100 of a vascular treatment device being torsionally rasped. Theexpanded bulbs of the distal portion are shown wrapped around a thrombus(e.g., clot) 500.

The tension may be applied throughout the torsional rasping bycontinually rotating the proximal portion 200 or at least not allowingthe proximal portion 200 to rotate in the opposite direction. Referringagain to the towel analogy, releasing the tension may allow the distalportion 100 to at least partially unfurl, which may, for example, allowtrapped clot and/or emboli to escape, although such escaped thrombi maybe captured by other parts of the distal portion 100.

In some embodiments, one of the bulbs (e.g., a distal-most bulb of thedistal portion 100 apposing the sidewalls of the vessel) can act as anembolic filter during a clot retrieval procedure (e.g., trapping emboli,such as emboli created during expansion of the distal portion 100 and/ortorsional rasping of the distal portion 100) such that no other,separate, or additional embolic filter is used. The thrombectomyprocedures described herein are different than embolic filters. Forexample, the devices 10, 20, 30, 40 can actively retrieve a clot, forexample according to the procedures described herein, rather thanpassively collecting emboli.

In some procedures, the devices 10, 20, 30, 40 described herein may beused as an embolic filter in combination with another type ofcatheter-based or wire-based system (e.g., during performance of anothervascular procedure such as angioplasty, atherectomy, aspiration,stenting, embolic coil insertion, intra-arterial thrombolysis, bypass,etc.), or even an additional thrombectomy device (e.g., a device 10 anda device 20). For example, a distal-most bulb of a distal portion 100may be deployed distal to the site of the procedure. In someembodiments, additional parts of the distal portion 100 may be deployedduring and/or after performance of a procedure. In certain suchembodiments, the distal portion 100 may be torsionally rasped (e.g., torotationally scrape sidewalls of a vessel after plaque may have beenloosened by angioplasty or atherectomy, to rotationally scrape theinside of a stent, to capture debris proximal to the distal-most bulb ofthe distal portion 100, etc.). In certain such embodiments, themicrocatheter 504 may be advanced slightly more distally to allow theother system to also be at least partially distal to the clot. The lumenof the proximal portion 200 and optionally the distal portion 100 may beused as a working channel for other devices.

The rotational direction may be clockwise or counterclockwise. Forexample, the handedness (left handed or right handed) of the user maymake a particular rotational direction more comfortable (e.g., turningthe proximal portion 200 towards the user's body). In some embodiments,a direction of rotation may be based at least partially on the design ofthe proximal portion 200. For example, referring again to FIGS. 16A and16B, if the proximal portion 200 includes slits with a positive angle250, then counterclockwise rotation may better transfer rotationalforces and if the proximal portion 200 includes slits with a negativeangle 250, then clockwise rotation may better transfer rotationalforces.

In some embodiments, the rotation of the distal portion 100 is less thanthe rotation of the proximal portion 200. For example, in someembodiments, a 360° rotation of the proximal portion 200 results in lessthan 360° rotation of the distal portion 100 (e.g., rotation of thedistal portion between about 90° and about 359°, between about 90° andabout 270°, between about 90° and about 180°, etc.). In someembodiments, a ratio of rotational forces at the proximal portion 100and the distal portion 200 are not 1:1. For example, the ratio may beless than 1:1 (e.g., 1:0.75, 1:0.5, or 1:0.25, etc.). In someembodiments, a non-1:1 ratio may provide a gentle rotation that canreduce the risk that the blood vessel is rotated, displaced, disrupted,or perforated. Resistance of a distal-most bulb or other bulbs of thedistal portion 100 apposing the sidewalls of the vessel may contributeto reduced rotation of the distal portion 100.

In some embodiments, a wire torque device, handle, or the like may beused to assist rotation of the proximal portion 200. In someembodiments, the proximal portion is rotated between about 90° and about3,000°, between about 360° and about 2,500°, or between about 720° andabout 1,440°. In some embodiments, the proximal portion is rotated atleast three full rotations (e.g., greater than about 1,080°). In someembodiments, the proximal portion is rotated at least six full rotations(e.g., greater than about 2,160°). The upper limit of the amount ofrotation may vary by device and by clot. In some embodiments, physicalforces may inhibit further rotation (e.g., the wires of the distalportion 100 and/or the clot can no longer be radially compressed). Insome embodiments, the diameter of the distal portion 100 may reduceenough that further rotation rotates the distal portion 100 does noteffect further torsional rasping.

In some embodiments in which torsional rasping is performed on softclots, the distal portion 100 of the device 10, 20, 30, 40 comprisesbulbs configured to expand from the collapsed state to the expandedstate substantially instantaneously (e.g., comprising super-elasticmaterial), and the clot may be entwined around the bulbs in the hillsand valleys.

In some embodiments in which torsional rasping is performed on hardclots, the distal portion 100 of the device 10, 20, 30, 40 comprisesbulbs configured to expand from the collapsed state to the expandedstate with a time-delayed expansion (e.g., comprising shape-memorymaterial), the torsional rasping may be performed while the distalportion 100 is in a secondary shape such as a twisted or spiral shape(e.g., occurring due to contact with blood at body temperature and/orwarm saline), and the clot may be entwined by that secondary shape.

FIG. 27L is a schematic diagram illustrating an example embodiment of atwo-way shape memory effect of a distal portion 100 of a vasculartreatment device, for example the distal portion 100 of device 10, 20,30, or 40. When the distal portion 100 is at a first temperature such asambient room temperature (e.g., about 25° C.), the distal portion 100 isin the collapsed configuration as illustrated in FIG. 27F. When thedistal portion 100 is at a second temperature (e.g., about 37° C.),which can be achieved on contact with blood at body temperature, thedistal portion 100 further expands to the expanded configuration asillustrated in FIGS. 27G and 27H, depending on the length of retractionof the microcatheter 504. When the distal portion 100 is at a thirdtemperature (e.g., about 18° C.), which can be achieved by injectingcold saline through the microcatheter 504, a distal access microcatheter530, or the guide catheter 502, the distal portion 100 foreshortens tograsp the thrombus (e.g., clot) 500 better in a twisted spiralconfiguration as illustrated in FIGS. 27K and 27L. In some embodiments,this twisting grabbing can occur without rotation of the proximalportion 200.

If the thrombus (e.g., clot) 500 is not adequately grasped, for exampleas evidenced during angiography, after stopping the injection of coldsaline through the microcatheter 504, a distal access microcatheter 530,or the guide catheter 502, the distal portion 100 returns back to thesecond temperature (e.g., about 37° C.) on continued contact with bloodat body temperature, and the distal portion 100 expands once again tothe expanded configuration as illustrated in FIGS. 27G and 27H. When thedistal portion 100 is once again exposed to a third temperature (e.g.,about 37° C.), which can again be achieved by injecting cold salinethrough the microcatheter 504, a distal access microcatheter 530, or theguide catheter 502, the distal portion 100 foreshortens again to graspthe thrombus 500 in a twisted spiral configuration as illustrated inFIGS. 27K and 27L. In some embodiments, this twisting grabbing can occurwithout rotation of the proximal portion 200. In some embodiments, thesecond twisting may better capture the thrombus 500 than the firsttwisting.

FIG. 27M is a schematic diagram illustrating the retraction of a distalportion 100 of a vascular treatment device and a thrombus 500. In someembodiments, the device 10, 20, 30, 40 may be proximally retracted(e.g., after torsional rasping or without torsional rasping), forexample by retracting (e.g., substantially simultaneously and/or at asimilar rate) the proximal portion 200 and the microcatheter 504 untilboth the proximal portion 200 and the microcatheter 504 are through theguide catheter and out of the body of the subject being treated. Duringthis retraction, the parts of the distal portion 100 that were expandedremain expanded and the parts of the distal portion 100 that were notexpanded remain in the contracted state. The proximal portion 200 andthe microcatheter 504 may continue to be retracted until the distalportion 100 and the clot are out of the guide catheter.

Negative suction pressure may be applied (e.g., using a crescendosuction pattern (e.g., as described with respect to FIG. 27I-2)) throughthe guide catheter 502 during proximal retraction. If no blood comes outafter stopping aspirating, then the user may know that something, suchas the clot, is blocking the guide catheter 502. A user may performthrombus aspiration until that blockage comes out, as described herein.When blood comes out, the user may, for example flush with fluid (e.g.,heparinized saline), perform post-thrombectomy angiogram, etc.

In some embodiments, the removed thrombus (e.g., clot) 500 may be placednext to a ruler 520 on a package containing the device 10, 20, 30, 40 oranother ruler. The user may compare the measured length of the removedthrombus (e.g., clot) 501 to the estimated (e.g., before the procedure)and/or known (e.g., measured during the procedure using radiopaquecrossings) length. FIG. 27N illustrates an example embodiment of acomparison of a thrombus 501 length to a ruler 520. The thrombus 501measures about 2 inches (approx. 5.1 cm). If the length of the removedthrombus 501 is substantially less than the estimated and/or knownlength, the user may deduce that the entire thrombus 500 was notremoved. The user may check the aspiration syringe or other equipmentfor any additional lengths of clot. Knowledge that some of the thrombus500 may have not been removed allows the user to figure out a furthertreatment strategy. As described above, such comparison and removalvalidation is generally not possible with devices that remove a portionof the thrombus 500 at a time (e.g., due to a fixed and limited workinglength).

FIG. 27O is a schematic diagram of a distal portion 100 of athrombectomy device acting as a filter device. In some embodiments, uponexpansion, the distal-most bulb or bulbs can appose the sidewalls of thevessel distal to the thrombus (e.g., clot) 500, and the distal-mostbulb(s) can act as a distal filter or entrapment mechanism that cancatch or collect pieces of thrombus (e.g., emboli) 500 that may becomeseparated during thrombectomy, an angioplasty, aspiration, stenting, orother vascular procedures.

FIG. 27P is a schematic diagram illustrating an example embodiment of atwo-way shape memory effect of the proximal portion 9700 of athrombectomy device, for example the proximal portion 200 of device 10,20, 30, or 40. When the proximal portion 9700 is at a first temperaturesuch as ambient room temperature (e.g., about 25° C.), the proximalportion 9700 is in a substantially linear configuration. When theproximal portion 9700 is at a second temperature (e.g., about 37° C.),which can be achieved on contact with blood at body temperature, some orall the proximal portion 9700 takes shape such as a gentle S-shape,which can mimic curves of the vessel anatomy, which can alleviate stresson the vessels. When the proximal portion 9700 is removed from the bodyafter a vascular procedure, for example a thrombectomy procedure, theparts of or all of the proximal portion 9700 may retain the shape.

If the thrombus (e.g., clot) 500 is not adequately removed after a firstthrombectomy attempt, for example as evidenced during angiography,reintroduction of the proximal portion 9700 through the hub 590 of themicrocatheter 504 may be difficult. The proximal portion 9700 may beexposed to a third temperature (e.g., about 18° C.) (e.g., by placementin a sterile bowl containing cold saline). Upon reaching the thirdtemperature, the proximal portion 9700 returns to the substantiallylinear configuration. This two-way shape memory effect of the proximalportion 9700 may be useful, for example, in vascular procedures that mayutilize multiple attempts.

In some embodiments, a proximal portion 200 having super-elasticity andthat has a substantially linear configuration shape set will attempt toreturn to that substantially linear configuration as the proximalportion bends in a tortuous blood vessel, which can straighten thetortuous blood vessel, which may lead to rupture of any perforatorvessels arising from the tortuous blood vessel. In some embodiments, aproximal portion 200 having a two-way shape memory effect may be gentleron blood vessels than a proximal portion 200 having super-elasticity.

Once the microcatheter 504, and, if used, a distal access microcatheter530, and the device 10, 20, 30, 40 are out of the subject and no furthertreatment is to be performed, the guide catheter 502 may be removed andthe subject sealed (e.g., stitching the entry point or using a bandageor dressing such as a Tegaderm®, available from 3M). The methodsdescribed above need not all be performed or performed in the orderrecited. Other steps can also be performed. For example, steps such asvessel access, drug treatment, and the like are generally omitted forclarity.

In some embodiments, the devices 10, 20, 30, 40 described herein can beused in the brain. In some embodiments, vasculature in the periphery canbe treated using the devices 10, 20, 30, 40 described herein. In someembodiments, coronary vessels may be treated the devices 10, 20, 30, 40described herein. In some embodiments, the abdominal aorta and branchesmay be treated using the devices 10, 20, 30, 40 described herein.

FIG. 28A is a schematic diagram of a guide catheter 502 proximal to ananeurysm 503 in vasculature. The aneurysm 503 illustrated in FIG. 28A isin the right middle cerebral artery, although other aneurysms 503 mayalso be treated, including sidewall aneurysms and bifurcation aneurysms.The guide catheter 502 is in the right internal carotid artery, forexample having been routed to that position as described above. Theaneurysm 503 may have been noted during CT scan angiography or MRIangiography or angiography with the guide catheter 502 or anothercatheter (e.g., a shuttle or a balloon guide catheter), for example inthe right internal carotid artery. A catheter angiogram may be performedusing the guide catheter 502 after positioning the guide catheter 502.

FIGS. 28B and 28C are schematic diagrams of a microwire 506 distal to ananeurysm 503 in vasculature and a microcatheter 504 over the microwire506. In some embodiments, referring again to FIG. 27I-1, a distal accessmicrocatheter 530 with a microcatheter 504 inserted inside the distalaccess microcatheter 530 may be through the guide catheter 502, which ispositioned in the right internal carotid artery proximal to the aneurysm503, and over a steerable microwire 506. A steerable microwire 506(e.g., having an outer diameter of about 0.014 inches (approx. 0.36 mm)is inserted into the microcatheter 504, extending some distance (e.g.,about 2 cm to about 4 cm) out of the distal end of the microcatheter504. In some embodiments, a distal access microcatheter 530 is not usedand the microcatheter 504 is advanced over the microwire 506. Themicrowire 506 can be advanced and steered for some distance into thepetrous and cavernous segments of the right internal carotid artery,followed by advancement of the microcatheter 504 over the microwire 506.The microwire 506 and the microcatheter 504 can be sequentially advancedinto the supraclinoid segment of the right internal carotid artery andthen into the right middle cerebral artery until the desired point inthe vasculature distal to the aneurysm 503 or lesion, for example byabout 0.5 mm to about 5 mm (e.g., into the superior M2 segment orinferior M2 segment of the middle cerebral artery). Other locations ofaneurysms 503 include, but are not limited to, the supraclinoid segmentof the right internal carotid artery and the anterior communicatingartery at the junction of the right A1 segment and A2 segments of theanterior cerebral arteries.

FIG. 28D is a schematic diagram of a microcatheter 504 distal to ananeurysm 503 in vasculature. The microwire 506 has been removed from themicrocatheter 504, leaving the microcatheter 504 distal to the aneurysm503. The distal end of the microcatheter 504 may range from about 5 mmto 45 mm (e.g., about 15 mm) distal to the aneurysm 503 or a lesion(e.g., in the superior segment of the right middle cerebral artery orthe inferior segment of the right middle cerebral artery). In someembodiments in which a distal access microcatheter 530 is used, thedistal end of the distal access microcatheter 530 may range from about 5mm to 50 mm (e.g., about 25 mm) proximal to the aneurysm 503 or a lesionin the vasculature (e.g., in the proximal middle cerebral artery, thesupraclinoid right internal carotid artery, or the cavernous segment ofthe right internal carotid artery for an aneurysm 503 in the rightmiddle cerebral artery).

Referring again to FIG. 27E, the distal portion 100 of vasculartreatment device (e.g., flow diverter) can be introduced into the hub590 of the microcatheter 504 through an introducer sheath 540 with thedistal portion 100 in the constrained state. The proximal portion 200 ofthe vascular treatment device is pushed to advance the device throughthe microcatheter 504. The device is advanced until the distal end ofthe distal portion 100 is proximate to the distal end of themicrocatheter 504, which is distal to the distal end of the aneurysm503. The microcatheter 504 is then retracted (e.g., unsleeved,unsheathed) while holding the proximal portion 200 still so that thelongitudinal position of the device is maintained.

FIG. 28E is a schematic diagram of an example embodiment of the distalportion 100 of a vascular treatment device being deployed distal to ananeurysm 503 in vasculature. The retraction of the microcatheter 504exposes the distal portion 100, from the distal end back, which canallow the exposed sections of the distal portion 100 to self-expand. Forexample, the distal portion 100 may include a wide-mouth distal neckand/or a distal-most bulb 9850 that can expand to appose the sidewallsof the vasculature distal to the aneurysm 503.

In some embodiments, exposed sections of the distal portion 100 canself-expand because the distal portion 100 includes at least somesuper-elastic filaments configured to self-expand, for example, due tostress-induced martensite (SIM) without any particular change intemperature. Super-elastic materials can expand substantiallyinstantaneously from a collapsed configuration to an expandedconfiguration when the unsheathed. In some embodiments, exposed sectionsof the distal portion 100 can self-expand because the distal portion 100includes at least some shape memory filaments that configured toself-expand, for example, due to temperature-activated austenitictransformation (e.g., upon a change in temperature such as greater thanroom temperature (about 25° C.) (e.g., to about body temperature(approx. 37° C.), less than room temperature (e.g., to about 18° C.),etc.). Shape-memory materials can expand slowly from a collapsedconfiguration to an expanded configuration when unsheathed upon contactwith warm fluid (e.g., blood at body temperature, warm saline) and/orcold fluid (e.g., cold saline).

In some embodiments, the shape memory effect of the shape memoryfilaments can be one-way (e.g., a stress-induced change in shape returnsto a baseline shape upon heating, with no change upon cooling). With theone-way shape memory effect, the material remembers one shape above acertain temperature. In some embodiments, the shape memory effect of theshape memory filaments can be two-way (e.g., a stress-induced change inshape returns close to baseline shape upon heating, and a second shapecan be achieved upon cooling). With the two-way shape memory effect, thematerial remembers a first shape above a first temperature and a secondshape below a second temperature.

FIG. 28F is a schematic diagram of an example embodiment of the distal100 portion of a vascular treatment device being deployed across ananeurysm 503 in vasculature. In contrast to a tubular device, forexample, the deployment of a distal portion 100 comprising bulbs andwide-mouthed necks 9850 across the mouth of an aneurysm can allow forbetter wall apposition and/or reduce the risk of an endo-leak.

FIG. 28G is a schematic diagram of an example embodiment of the distalportion 9600 of FIG. 6G deployed across an aneurysm 9645 in vasculature.Referring again to FIG. 6G, the distal portion 9600 may be useful, forexample, in aneurysms 9645 proximal to a vessel bifurcation, forexample, for deployment of the high pore size distal bulb 9603 in theproximal M1 segment of the middle cerebral artery 9640 and the high poresize middle bulb 9605 at the internal carotid artery bifurcation nearthe origin of the middle cerebral artery 9640 and the anterior cerebralartery 9630, which can allow blood flow into the arteries 9630, 9640 andtheir perforators distal to the aneurysm 9645, which can inhibit orprevent occlusion of blood flow to the arteries 9630, 9640, which couldotherwise lead to life-threatening stroke. In some embodiments,deployment of the small pore size proximal segment 9604 across ananeurysm 9645 located in the supraclinoid internal carotid artery 9635,in the illustrated example not involving the internal carotid arterybifurcation, can aid in thrombosis of the aneurysm 9645. The bulbs 9603,9605, 9607, the wide-mouthed necks in between the bulbs 9614 and 9616,the wide mouthed proximal neck 9618, and the distal neck 9612 can allowprovide good wall apposition including the site of vessel bifurcation,which can inhibit or prevent the risk of an endo-leak into the aneurysm9645. In some embodiments, the force/resistance (e.g., radial force) ofthe bulbs and/or necks is in a range sufficient to slightly expand thetarget vessel(s) in the range of about 0% to about 30%, and the shapesof the bulbs and necks are at least partially preserved. In someembodiments, the radial force of the bulbs and/or necks is in a rangesufficient to appose the sidewalls of the vessel to inhibit or preventan endo-leak, but not sufficient to expand the vessel, and the shapes ofthe bulbs and necks are no longer preserved such that the shape of thedistal portion 9600 is substantially tubular, whether tapered ornon-tapered, for example based on the shape of the target vessel.

FIG. 28H is a schematic diagram of an example embodiment of the distalportion 11100 of FIG. 7B deployed across an aneurysm 11150 invasculature. The distal portion 11100 may be useful, for example, fordeployment in fusiform aneurysms at a vessel bifurcation such as anabdominal aortic aneurysm (AAA) 11150 illustrated in FIG. 28H. In someembodiments, a procedure may be performed percutaneously and entirelythrough one arterial access, for example the left common femoral arteryand the left common iliac artery 11140. For example, deployment of thelarge pore sized proximal lateral neck 11120 in the left common iliacartery 11140 and the large pore sized proximal medial neck 11125 in theright common iliac artery 11160 can allow blood flow into thesearteries, which can inhibit or prevent occlusion of these arteries,which could otherwise lead to renal failure or life-threatening limbischemia. In some embodiments, deployment of the large pore sized distalneck 11130 in the supra-renal or infra-renal abdominal aorta can allowblood flow into the renal arteries 11145 and their branches, which caninhibit or prevent occlusion of blood flow to the renal arteries 11145,which could otherwise lead to kidney failure. In some embodiments,deployment of the small pore sized spherical proximal bulb 11105, theelongate distal bulb 11110, and the neck 11115 between the bulbs 11105,11110 across the abdominal aortic aneurysm 11150 in the infra-renalabdominal aorta can aid in thrombosis of the aneurysm 11150. The largepore sized proximal lateral neck 11120 may be deployed in the leftcommon iliac artery 11140. Given the relatively short length and largepore size of the proximal medical neck 11125, the neck 11125 can bedeployed into the origin of the right common iliac artery 11160 whilethe proximal lateral neck 11120 is deployed in the left common iliacartery 11140, which can allow blood flow into these arteries, which caninhibit or prevent occlusion of blood flow to these arteries, whichcould otherwise lead to renal failure or life-threatening limb ischemia.In some embodiments, the force/resistance (e.g., radial force) of thebulbs and/or necks is in a range sufficient to slightly expand thetarget vessel(s) in the range of about 0% to about 30%, and the shapesof the bulbs and necks are at least partially preserved. In someembodiments, the radial force of the bulbs and/or necks is in a rangesufficient to appose the sidewalls of the vessel to inhibit or preventan endo-leak, but not sufficient to expand the vessel, and the shapes ofthe bulbs and necks are no longer preserved such that the shape of thedistal portion 11100 is substantially tubular, whether tapered ornon-tapered, for example based on the shape of the target vessel.

FIG. 28I is a schematic diagram of an example embodiment of the distalportion 9000 FIG. 6A deployed across an aneurysm 9050 in vasculature.The distal portion 9000 may be useful, for example, for deployment ofthe small pore size middle segment 9002 across a wide-mouthedposterior-communicating artery brain arterial aneurysm 9050, which islocated in the supraclinoid segment of the internal carotid artery 9030,which can aid in thrombosis of the aneurysm 9050. Deployment of the highpore size proximal segment 9006 and the high pore size distal segment9004 on either side of the aneurysm 9050 can allow blood flow intoarteries proximal and distal to the aneurysm 9050, for example to theproximal ophthalmic artery 9040 and the distal anterior choroidal artery9045 and superior hypophyseal artery distally 9035, which can inhibit orprevent occlusion of the arteries 9035, 9040, 9045 and/or resultingdysfunction (e.g., occlusion of the ophthalmic artery 9040 can causeblindness, occlusion of the anterior choroidal artery 9045 can causeparalysis of the arms and legs). The bulbs and wide-mouthed necks of thedistal portion 9000 can provide good wall apposition, including at thesite of vessel bifurcation, which can inhibit or prevent the risk of anendo-leak into the aneurysm 9050. In some embodiments, theforce/resistance (e.g., radial force) of the bulbs and/or necks is in arange sufficient to slightly expand the target vessel(s) in the range ofabout 0% to about 30%, and the shapes of the bulbs and necks are atleast partially preserved. In some embodiments, the radial force of thebulbs and/or necks is in a range sufficient to appose the sidewalls ofthe vessel to inhibit or prevent an endo-leak, but not sufficient toexpand the vessel, and the shapes of the bulbs and necks are no longerpreserved such that the shape of the distal portion 9000 issubstantially tubular, whether tapered or non-tapered, for example basedon the shape of the target vessel.

FIG. 28J is a schematic diagram of an example embodiment of the distalportion 9100 of FIG. 6B deployed across an aneurysm 9135 in vasculature.The distal portion 9100 may be useful, for example, for deployment ofthe small pore size distal segment 9110 across a proximal middlecerebral artery M2 segment brain arterial aneurysm 9135, which islocated near the distal M1 segment of the middle cerebral artery 9130,which can aid in the thrombosis of the aneurysm 9135. Deployment of thehigh pore size proximal segment 9120 across the distal M1 segment of themiddle cerebral artery 9130 can allow blood flow into the perforatorsarising from the distal M1 segment of the middle cerebral artery 9130,for example the proximal lateral lenticulo-striate perforating arteries9140, 9145, which can inhibit or prevent occlusion of such perforators9140, 9145 and/or resulting dysfunction (e.g., occlusion of thelenticulo-striate perforators 9140, 9145 can cause paralysis of the armsand legs). The bulbs and wide-mouthed necks of the distal portion 9100can provide good wall apposition, including at the site of vesselbifurcation, which can inhibit or prevent the risk of an endo-leak intothe aneurysm 9135. In some embodiments, the force/resistance (e.g.,radial force) of the bulbs and/or necks is in a range sufficient toslightly expand the target vessel(s) in the range of about 0% to about30%, and the shapes of the bulbs and necks are at least partiallypreserved. In some embodiments, the radial force of the bulbs and/ornecks is in a range sufficient to appose the sidewalls of the vessel toinhibit or prevent an endo-leak, but not sufficient to expand thevessel, and the shapes of the bulbs and necks are no longer preservedsuch that the shape of the distal portion 9100 is substantially tubular,whether tapered or non-tapered, for example based on the shape of thetarget vessel.

FIG. 28K is a schematic diagram of an example embodiment of the distalportion 9200 of FIG. 6C deployed across an aneurysm 9240 in vasculature.The distal portion 9200 may be useful, for example, for the deploymentof the high pore size distal segment 9210 in internal carotid artery9230 distal to the cavernous aneurysm 9240, which can allow blood flowinto the distal artery 9235, for example the ophthalmic artery, whichcan inhibit or prevent occlusion of the artery 9235 and/or resultingdysfunction (e.g., occlusion of the ophthalmic artery 9235 can causeblindness). Deployment of the small pore size proximal segment 9220across a brain aneurysm 9240 located in the distal cavernous segment ofthe internal carotid artery 9230 can aid in the thrombosis of theaneurysm 9240. The bulbs and wide-mouthed necks of the distal portion9200 can provide good wall apposition, including at the site of vesselbifurcation, which can inhibit or prevent the risk of an endo-leak intothe aneurysm 9240. In some embodiments, the force/resistance (e.g.,radial force) of the bulbs and/or necks is in a range sufficient toslightly expand the target vessel(s) in the range of about 0% to about30%, and the shapes of the bulbs and necks are at least partiallypreserved. In some embodiments, the radial force of the bulbs and/ornecks is in a range sufficient to appose the sidewalls of the vessel toinhibit or prevent an endo-leak, but not sufficient to expand thevessel, and the shapes of the bulbs and necks are no longer preservedsuch that the shape of the distal portion 9200 is substantially tubular,whether tapered or non-tapered, for example based on the shape of thetarget vessel.

FIG. 28L is a schematic diagram of an example embodiment of the distalportion 9300 of FIG. 6D deployed across aneurysms 9335, 9340 invasculature. The distal portion 9300 may be useful, for example, whentwo aneurysms 9335, 9340 along a vessel 9330 are separated by a segmentincluding a branch vessel 9350. For example, deployment of the smallpore size distal segment 9304 across a posterior communicating artery(P-comm) brain aneurysm 9335 in the supraclinoid segment of the internalcarotid artery 9330 and deployment of the small pore size proximalsegment 9306 across a distal cavernous internal carotid artery aneurysm9340 in the internal carotid artery 9330 can aid in the thrombosis ofthe aneurysms 9335, 9340, and deployment of the high pore size middlesegment 9320 between the P-comm aneurysm 9335 and the distal cavernousinternal carotid artery aneurysm 9340 can allow blood flow into theophthalmic artery 9350, which can inhibit or prevent occlusion of theophthalmic artery 9350, which could otherwise cause blindness. The bulbsand wide-mouthed necks of the distal portion 9200 can provide good wallapposition, including at the site of vessel bifurcation, which caninhibit or prevent the risk of an endo-leak into the aneurysms 9335,9340. In some embodiments, the force/resistance (e.g., radial force) ofthe bulbs and/or necks is in a range sufficient to slightly expand thetarget vessel(s) in the range of about 0% to about 30%, and the shapesof the bulbs and necks are at least partially preserved. In someembodiments, the radial force of the bulbs and/or necks is in a rangesufficient to appose the sidewalls of the vessel to inhibit or preventan endo-leak, but not sufficient to expand the vessel, and the shapes ofthe bulbs and necks are no longer preserved such that the shape of thedistal portion 9300 is substantially tubular, whether tapered ornon-tapered, for example based on the shape of the target vessel.

FIG. 28M is a schematic diagram of an example embodiment of the distalportion 9400 of FIG. 6E deployed across an aneurysm 9435 in vasculature.The distal portion 9400 may be useful, for example, when an aneurysm9435 is between several arteries and/or perforators. For example,deployment of the small pore size middle segment 9430 across adissecting pseudo-aneurysm 9435 in the V4 segment of the vertebralartery 9445 can aid in thrombosis of the aneurysm 9435, and deploymentof the high pore size proximal segment 9404 and the high pore sizedistal segment 9402 across the arteries proximal and distal to theaneurysm 9435 can allow blood flow into these arteries, for example theproximal posterior inferior cerebellar artery (PICA) 9470 and the distalbasilar artery 9440 and its perforators 9460, 9465, which can inhibit orprevent occlusion of these arteries and/or resulting dysfunction (e.g.,occlusion of the PICA 9470 can cause balance problems while walking,occlusion of the basilar artery 9440 or its perforators can cause lifethreatening strokes, etc.). The medium braid angle segments 9406, 9408have medium pore sizes, which can allow for variability and error whiledeploying the distal portion 9400, which can inhibit or preventocclusion of these arteries or their perforators. The contralateral V4segment of the vertebral artery 9450 can supply the contralateral PICA9455 and the basilar artery 9440 through the woven neck and bulb of thehigh pore size distal segment 9402. The bulbs and wide-mouthed necks ofthe distal portion 9400 can provide good wall apposition, including atthe site of vessel bifurcation, which can inhibit or prevent the risk ofan endo-leak into the aneurysm 9435. In some embodiments, theforce/resistance (e.g., radial force) of the bulbs and/or necks is in arange sufficient to slightly expand the target vessel(s) in the range ofabout 0% to about 30%, and the shapes of the bulbs and necks are atleast partially preserved. In some embodiments, the radial force of thebulbs and/or necks is in a range sufficient to appose the sidewalls ofthe vessel to inhibit or prevent an endo-leak, but not sufficient toexpand the vessel, and the shapes of the bulbs and necks are no longerpreserved such that the shape of the distal portion 9400 issubstantially tubular, whether tapered or non-tapered, for example basedon the shape of the target vessel.

FIG. 28N is a schematic diagram of an example embodiment of the distalportion 9500 of FIG. 6F deployed across an aneurysm 9540, 9550 invasculature. The distal portion 9500 may be useful, for example, fordeployment of the small pore size middle segment 9504 across a fusiformaortic aneurysm 9540, 9550 located in the infra-renal abdominal aorta9530, and not involving the aorto-iliac bifurcation, which can aid inthrombosis of the aneurysm 9540, 9950. Deployment of the high pore sizeproximal segment 9506 and the high pore size distal segment 9502 acrossarteries proximal and distal to the aneurysm 9540, 9550 can allow bloodflow into these arteries, for example the distal bilateral renalarteries 9535, 9545 and the proximal intercostal and lumbar arteries,which can inhibit or prevent occlusion and/or resulting dysfunction(e.g., lack of blood flow to the kidneys can lead to renal failure,occlusion of the intercostal and lumbar arteries could lead to bowel andbladder dysfunction, etc.). The bulbs 9503, 9505, 9507, the wide-mouthedneck 9514 between the bulbs 9503, 9505, the wide-mouthed neck 9516between the bulbs 9505, 9507, the wide-mouthed proximal neck 9518, andthe wide-mouth distal neck 9512 of the distal portion 9500 can providegood wall apposition, which can inhibit or prevent the risk of anendo-leak into the aneurysm 9540, 9550. In some embodiments, theforce/resistance (e.g., radial force) of the bulbs and/or necks is in arange sufficient to slightly expand the target vessel(s) in the range ofabout 0% to about 30%, and the shapes of the bulbs and necks are atleast partially preserved. In some embodiments, the radial force of thebulbs and/or necks is in a range sufficient to appose the sidewalls ofthe vessel to inhibit or prevent an endo-leak, but not sufficient toexpand the vessel, and the shapes of the bulbs and necks are no longerpreserved such that the shape of the distal portion 9500 issubstantially tubular, whether tapered or non-tapered, for example basedon the shape of the target vessel.

FIG. 28O is a schematic diagram of an example embodiment of the distalportion 11000 of FIG. 7A deployed across a bifurcation aneurysm 11005 invasculature. The distal portion 11000 may be useful in aneurysms at avessel bifurcation, for example, for deployment of the large pore sizeddistal lateral neck 11019 in the proximal M1 segment of the middlecerebral artery 11015 and the large pore sized distal medial neck 11018in the A1 segment of the anterior cerebral artery 11025, which can allowblood flow into these arteries, which can inhibit or prevent occlusionof blood flow to these arteries, which could otherwise lead tolife-threatening stroke. In some embodiments, deployment of the smallpore sized spherical distal bulb 11012 across the aneurysm 11005 in thedistal internal carotid artery 11035 bifurcation can aid in thrombosisof the aneurysm 11005. In some embodiments, deployment of the large poresized proximal segment of the distal portion 11000, including thewide-mouthed neck 11016, the proximal elongate bulb 11014, and theproximal neck 11017, in the distal supra-clinoid internal carotid artery11035 can allow blood flow into the branches arising from the distalsupra-clinoid arteries, which can inhibit or prevent occlusion of bloodflow to these arteries, which could otherwise lead to life-threateningstroke. In some embodiments, the force/resistance (e.g., radial force)of the bulbs and/or necks is in a range sufficient to slightly expandthe target vessel(s) in the range of about 0% to about 30%, and theshapes of the bulbs and necks are at least partially preserved. In someembodiments, the radial force of the bulbs and/or necks is in a rangesufficient to appose the sidewalls of the vessel to inhibit or preventan endo-leak, but not sufficient to expand the vessel, and the shapes ofthe bulbs and necks are no longer preserved such that the shape of thedistal portion 11000 is substantially tubular, whether tapered ornon-tapered, for example based on the shape of the target vessel.

FIG. 28P is a schematic diagram of an example embodiment of the distalportion 11300 of FIG. 6H deployed across a side-wall aneurysm 503 invasculature. The distal portion 11300 may be useful, for example, fordeployment of the small pore size second portion 11312 of the middlesegment 11310 across a side-wall basilar arterial brain aneurysm 503,which can aid in thrombosis of the aneurysm 503. Deployment of the highpore size proximal segment 11315, the high pore size distal segment11305, and the high pore size first portion 11311 of the middle segment11310 across arteries 9460, 9465 proximal and distal to the aneurysm 503can allow blood flow into these arteries, for example the proximalanterior-inferior cerebellar arteries, the distal basilar perforators,and/or the distal superior cerebellar arteries, which can inhibit orprevent occlusion of the basilar perforators and the other branches9460, 9465 and/or resulting dysfunction, which could otherwise cause abrainstem stroke with paralysis of the arms and legs. In someembodiments, the force/resistance (e.g., radial force) of the bulbsand/or necks is in a range sufficient to slightly expand the targetvessel(s) in the range of about 0% to about 30%, and the shapes of thebulbs and necks are at least partially preserved. In some embodiments,the radial force of the bulbs and/or necks is in a range sufficient toappose the sidewalls of the vessel to inhibit or prevent an endo-leak,but not sufficient to expand the vessel, and the shapes of the bulbs andnecks are no longer preserved such that the shape of the distal portion11300 is substantially tubular, whether tapered or non-tapered, forexample based on the shape of the target vessel.

FIG. 28Q is a schematic diagram of an example embodiment of the distalportion 9900 of FIG. 6J deployed across a vascular malformation 507 invasculature. The distal portion 9900 may be useful, for example, invascular malformations such as an arterio-venous fistula 507. Forexample, deployment of the high pore size segment 9902 in the transversecerebral venous sinus and the high pore size proximal segment 9906 atthe internal jugular vein near the base of skull can allow for normalvenous drainage into these veins, which can inhibit or prevent occlusionof venous drainage from these venous sinuses (e.g., the vein of Labbe9931, the superior pertrosal sinus 9932, the inferior petrosal sinus9934, etc.), inadvertent occlusion of which could otherwise lead tolife-threatening stroke. Deployment of the small pore size middlesegment 9904 across the site 9933 of the arterio-venous fistula drainageinto the sigmoid cerebral venous sinus can aid in thrombosis of thearterio-venous fistula 507. The bulbs and wide-mouthed proximal anddistal necks of the distal portion 9900 can provide good wall appositionin the cerebral venous sinuses and veins. In some embodiments, theforce/resistance (e.g., radial force) of the bulbs and/or necks is in arange sufficient to slightly expand the target vessel(s) in the range ofabout 0% to about 30%, and the shapes of the bulbs and necks are atleast partially preserved. In some embodiments, the radial force of thebulbs and/or necks is in a range sufficient to appose the sidewalls ofthe vessel to inhibit or prevent an endo-leak, but not sufficient toexpand the vessel, and the shapes of the bulbs and necks are no longerpreserved such that the shape of the distal portion 9900 issubstantially tubular, whether tapered or non-tapered, for example basedon the shape of the target vessel.

FIG. 29A is a schematic diagram of an example embodiment of the distalportion 11400 of FIG. 7C deployed across a fistula. A trans-femoral,trans-venous approach may be used to treating an arterio-venous fistulasuch as a carotid cavernous fistula. The femoral vein can act as apercutaneous entry point. As described above with respect to thecatheter angiogram, either leg can be used because both point towardsthe head, and, for peripheral lesions in one leg, the non-affected legcan be used.

Deployment of the distal portion 11400 may be as provided herein. Aguide catheter and a dilator are partially inserted into the entrypoint. A steerable guidewire (e.g., having a length between about 150 cmand about 180 cm) is inserted into the guide catheter and the dilator,extending some distance (e.g., about 2 inches (approx. 5 cm)) out of thedistal end of the dilator. The steerable guidewire can be advanced andsteered for some distance, followed by advancement of the guide catheterand dilator over the steerable guidewire. The dilator is then removed.The steerable guidewire and the guide catheter can be sequentiallyadvanced into the inferior vena cava, through the right atrium of theheart, into the brachiocephalic vein, until the desired point in thevasculature (e.g., internal jugular vein at the base of skull). Thesteerable guidewire is then removed, and the guide catheter is left inplace. The desired point of the vasculature where advancement ceases maybe the point where further advancement of the dilator could perforatethe vasculature.

In some embodiments, referring again to FIG. 27A, a microcatheter 504may be advanced over a steerable microwire 506 and through a guidecatheter 502 positioned in the internal jugular vein at the base ofskull proximal to the arterio-venous fistula. A steerable microwire 506(e.g., having an outer diameter of about 0.014 inches (approx. 0.36 mm)is inserted into the microcatheter 504, extending some distance (e.g.,about 2 cm to about 4 cm) out of the distal end of the microcatheter504. In some embodiments, a distal access microcatheter 530 is be usedand the microcatheter 504 is advanced over the microwire 506. Themicrowire 506 can be advanced and steered for some distance into thesigmoid and transverse cerebral venous sinuses, followed by advancementof the microcatheter 504 over the microwire 506. The microwire 506 andthe microcatheter 504 can be sequentially advanced until the desiredpoint in the vasculature (e.g., into the cavernous sinus). The microwire506 is then removed or retracted while the microcatheter 504 is inposition.

The distal portion 11400 may be useful, for example, as a flow disrupterin fistulas, which are abnormal communications between two hollowcavities. For example, if the distal portion 11400 in the cavernousvenous sinus is deployed such that the low pore size bulbs 11435, 11425are in the left cavernous venous sinus 11455, the low pore size bulbsare 11405, 11415 in the right cavernous venous sinus 11450, and the highpore size neck 11424 is between the two cavernous venous sinuses 11450,11455, the low pore size segments can cause flow disruption bydecreasing flow into the cavernous venous sinus, which can aid inthrombosis of the carotid-cavernous fistula. Deployment of the high poresize wide-mouthed neck 11424 between the two cavernous sinuses 11450,11455 can serve as a soft scaffold between the two cavernous venoussinuses 11450, 11455, which can aid in thrombosis of thecarotid-cavernous fistula.

FIG. 29B is a schematic diagram of an example embodiment of the distalportion 11600 of FIG. 7D deployed in a cardiac wall aneurysm 11650. Atrans-femoral, trans-arterial approach may be used to treat a cardiacwall aneurysm 11650 such as a ventricular wall aneurysm. The femoralartery can act as a percutaneous entry point. As described above withrespect to the catheter angiogram, either leg can be used because bothpoint towards the heart.

Deployment of the distal portion 11600 may be as provided herein. Aguide catheter and a dilator are partially inserted into the entrypoint. A steerable guidewire (e.g., having a length between about 150 cmand about 180 cm) is inserted into the guide catheter and the dilator,extending some distance (e.g., about 2 inches (approx. 5 cm)) out of thedistal end of the dilator. The steerable guidewire can be advanced andsteered for some distance, followed by advancement of the guide catheterand dilator over the steerable guidewire. The dilator is then removed.The steerable guidewire and the guide catheter can be sequentiallyadvanced into the descending abdominal aorta 11655, through the aorticarch 11660, until the desired point in the vasculature (e.g., the leftventricle 11665 of the heart). The steerable guidewire is then removed,and the guide catheter is left in place. The desired point of thevasculature where advancement ceases may be the point where furtheradvancement of the dilator could perforate the vasculature. Aventriculogram of the heart may be performed using a 4 Fr (e.g., about1.33 mm) or a 5 Fr (e.g., about 1.67 mm) pig-tail shaped diagnosticcatheter advanced through the guide catheter, which is in stableposition within the left ventricle 11665. Dye comprising iodine (e.g.,iohexyl, iodixanol, etc.) is injected through the pig-tail shapeddiagnostic catheter for direct imaging of the ventricular wall aneurysm11160. The pig-tail catheter is then removed with the guide catheter instable position within the left ventricle 11665.

In some embodiments, referring again to FIG. 27A, a microcatheter 504may be advanced over a steerable microwire 506 and through a guidecatheter 502 positioned in the left ventricle 11665 proximal to theventricular wall aneurysm 11160. A steerable microwire 506 (e.g., havingan outer diameter of about 0.014 inches (approx. 0.36 mm)) is insertedinto the microcatheter 504, extending some distance (e.g., about 2 cm toabout 4 cm) out of the distal end of the microcatheter 504. In someembodiments, a distal access microcatheter 530 may be used, and themicrocatheter 504 is advanced over the microwire 506 and through thedistal access microcatheter 530. The microwire 506 can be advanced andsteered for some distance into the ventricular wall aneurysm 11650,followed by advancement of the microcatheter 504 over the microwire 506.The microwire 506 and the microcatheter 504 can be sequentially advancedinto the dome of the ventricular wall aneurysm 11650. The microwire 506is then removed or retracted while the microcatheter 504 is in position.

The distal portion 11600 may be useful, for example, in ventricular wallaneurysms 11650. For example, deployment of the small pore size proximalbulb 11605 across the mouth of the ventricular wall aneurysm 11650 cancause flow disruption by decreasing flow into the ventricular wallaneurysm 11650, which can aid in thrombosis of the ventricular wallaneurysm 11650. Deployment of the high pore size middle bulb 11615 andhigh pore size distal bulb 11625 in the dome of the ventricular wallaneurysm 11650 can cause flow disruption within the aneurysm 11650 byforming a soft scaffold within the aneurysm 11650, which can aid inthrombosis of the aneurysm 11650. The distal neck 11606 is short and hasa low braid angle, which can provide soft deployment of the distalportion 11600 within the dome of the aneurysm 11650. The bulbs 11605,11615, 11625, the necks 11602, 11604, and the distal neck 11606 of thedistal portion 11600 can provide good wall apposition within theventricular wall aneurysm 11650.

FIG. 29C is a schematic diagram of an example embodiment of the distalportion 11500 of FIG. 7E deployed in the left atrial appendage 11530 ofthe heart. A trans-femoral, trans-venous approach may be used foroccluding the left atrial appendage 11530. The femoral vein can act as apercutaneous entry point. As described above with respect to thecatheter angiogram, either leg can be used because both point towardsthe heart.

Deployment of the distal portion 11500 may be as provided herein. Aguide catheter and a dilator are partially inserted into the entrypoint. A steerable guidewire (e.g., having a length between about 150 cmand about 180 cm) is inserted into the guide catheter and the dilator,extending some distance (e.g., about 2 inches (approx. 5 cm)) out of thedistal end of the dilator. The steerable guidewire can be advanced andsteered for some distance, followed by advancement of the guide catheterand dilator over the steerable guidewire. The dilator is then removedfrom the distal inferior vena cava. The steerable guidewire and theguide catheter can be sequentially advanced into the inferior vena cava,through the right atrium of the heart, and, if the foramen ovale ispatent, then the guide catheter is advanced over the steerable guidewirefrom the right atrium into the left atrium until the desired point inthe vasculature (e.g., the left atrium of the heart proximal to the leftatrial appendage 11530). The steerable guidewire is then removed, andthe guide catheter is left in place. If a pre-existing foramen ovale isnot patent, then a percutaneous entry into the superior vena cava can beperformed. Using a needle and stylet, an iatrogenic hole or perforationis created near the fossa ovalis in the septal wall of the atrium.

In some embodiments, referring again to FIG. 27A, a microcatheter 504may be advanced over a steerable microwire 506 and through a guidecatheter 502 positioned in the left atrium proximal to the orifice ofthe left atrial appendage 11530. A steerable microwire 506 (e.g., havingan outer diameter of about 0.014 inches (approx. 0.36 mm)) is insertedinto the microcatheter 504, extending some distance (e.g., about 2 cm toabout 4 cm) out of the distal end of the microcatheter 504. In someembodiments, a distal access microcatheter 530 may be used, and themicrocatheter 504 is advanced over the microwire 506 and through thedistal access microcatheter 530. The microwire 506 can be advanced andsteered for some distance into the mouth of the left atrial appendage11530. The microwire 506, and the microcatheter 504, can be sequentiallyadvanced dome of the left atrial appendage 11530. The microwire 506 isthen removed or retracted while the microcatheter 504 is in position.

The distal portion 11500 may be useful, for example, as a flow disrupterin the left atrial appendage 11530 within the heart. For example,deployment of the small pore size proximal bulbs 11512, 11514 across themouth of the left atrial appendage 11530 can cause flow disruption bydecreasing flow into the left atrial appendage 11530, which can aid inthrombosis of the left atrial appendage 11530, which can decrease therisk of stroke in patients with atrial fibrillation and/or reduce oreliminate the need for long term anti-coagulation. Deployment of thehigh pore size distal bulbs 11516, 11518 inside the dome of the leftatrial appendage 11530 can cause flow disruption within the left atrialappendage 11530 by forming a soft scaffold within the left atrialappendage 11530, which can aid in thrombosis of the left atrialappendage 11530. The distal neck 65 is short and has a low braid angle,which can provide soft deployment of the distal portion 11500 within thedome of the left atrial appendage 11530. The proximal neck 11522 isshort and has a high braid angle, which can inhibit or prevent any bloodflow into the dome of the left atrial appendage 11530. The bulbs and thewide mouthed necks between the bulbs of the distal portion 11500 canprovide good wall apposition within the left atrial appendage 11530.

The distal portions 100 described herein that are deployed invasculature may be releasably or non-releasably coupled to a proximalportion 200. For example, after positioning at the site of thevasculature, the distal portion 100 may be mechanically,electrolytically, chemically, etc. released to act as an endoprosthesis.For another example, after positioning at the site of the vasculature,the distal portion 100 may remain only for so long as the treatmenttakes place, whereupon it may be removed. In certain such embodiments,for example, the distal portion 100 may act as a scaffolding duringinsertion or packing of coils or other embolic material (e.g., fluidsuch as Onyx®, available from Covidien) into an aneurysm.

The devices 10, 20, 30, 40 described herein may be gentle and safe onthe fragile human blood vessels, customizable by a user to the length ofthe clot or clot burden, visible under X-ray fluoroscopy, reach thesmallest of human blood vessels, compatible with torsional rasping ofthe clot, have bonding zones or attachment points that are strong evenbetween dissimilar metals or alloys to avoid the risk of any fracturepoints, and/or include proximal portions 200 that provide good proximalsupport and good distal flexibility. Some embodiments can provide one ormore, or all, of the advantages described herein.

Although described herein in detail with respect to blood vessels, thedevices and methods described herein can be used in any appropriate partof the body, for example having a lumen (e.g., blood vessels (e.g.,cardiac, peripheral, neuro), biliary ducts, digestive orgastrointestinal tracts, pulmonary tracts, etc.).

In some embodiments, the devices and methods described herein can beused in conjunction with drug therapy. For example, a drug or agent(e.g., r-tpa, heparin, taxol, etc.) can be injected through themicrocatheter, through the lumen of the proximal portion 200 and/or alumen created by the textile structure 158 of the distal portion 100, orseparately before, during, or after deployment of at least a segment ofthe distal portion 100.

The following references are herein incorporated by reference in theirentirety: (1) SARTI et al., Intl trends in mortality from stroke, 1968to 1994, Stroke, 2000; vol. 31, pp. 1588-1601; (2) WOLF et al.,Epidemiology of Stroke, In: BARNETT et al., eds., Stroke:Pathophysiology, Diagnosis, and Management, 3rd Ed., New York, N.Y.:Churchill Livingstone, 1998, pp. 6-7; (3) ADAMS et al., Guidelines forthe early management of patients with ischemic stroke: A scientificstatement from the Stroke Council of the American Stroke Association,Stroke, 2003, vol. 34, pp. 1056-1083; (4) RYMER et al., Organizingregional networks to increase acute stroke intervention, Neurol. Res.,2005, vol. 27, pp. 9-16; and (5) FURLAN et al., Intra-arterialprourokinase for acute ischemic stroke; The PROACT II study: Arandomized controlled trial, Prolyse in Acute Cerebral Thromboembolism,JAMA, 1999, vol. 282, pp. 2003-2011.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the various embodiments described and the appended claims.Any methods disclosed herein need not be performed in the order recited.The methods disclosed herein include certain actions taken by apractitioner; however, they can also include any third-party instructionof those actions, either expressly or by implication. For example,actions such as “torsionally rasping a distal portion of a thrombectomydevice” include “instructing the torsionally rasping of a distal portionof a thrombectomy device.” The ranges disclosed herein also encompassany and all overlap, sub-ranges, and combinations thereof. Language suchas “up to,” “at least,” “greater than,” “less than,” “between,” and thelike includes the number recited. Numbers preceded by a term such as“about” or “approximately” include the recited numbers. For example,“about 3 mm” includes “3 mm.”

What is claimed is:
 1. A method of disrupting flow through a fistula,the method comprising: advancing a microcatheter through a guidecatheter, the guide catheter having a distal end at a first point invasculature, the microcatheter having a distal end; advancing asteerable microwire through the guide catheter, the steerable microwireextending distal to the distal end of the microcatheter; after advancingthe steerable microwire through the guide catheter, further advancingand steering the steerable microwire to a second point in thevasculature, the fistula being proximate to the second point in thevasculature; after further advancing and steering the steerablemicrowire, advancing the microcatheter over the steerable microwire tothe second point in the vasculature; after further advancing themicrocatheter over the steerable microwire to the second point in thevasculature, removing the steerable microwire; advancing a flowdisruptor through the microcatheter to the second point in thevasculature, the flow disruptor comprising, in an expanded state: afirst bulb having a first braid angle, a second bulb, a first neckbetween the first bulb and the second bulb, a third bulb, a second neckbetween the second bulb and the third bulb, a fourth bulb having asecond braid angle, the second neck having a third braid angle less thanthe first braid angle and the second braid angle, and a third neckbetween the third bulb and the fourth bulb; expanding the first bulb andthe second bulb on a first side of the fistula; extending the secondneck through the fistula; and expanding the third bulb and the fourthbulb on a second side of the fistula.
 2. The method of claim 1, whereinthe first point in the vasculature is an internal jugular vein at a baseof a skull.
 3. The method of claim 1, wherein expanding the first bulband the second bulb on the first side of the fistula comprises expandingthe first bulb and the second bulb in a left cavernous sinus, andwherein expanding the third bulb and the fourth bulb on the second sideof the fistula comprises expanding the third bulb and the fourth bulb ina right cavernous sinus.
 4. The method of claim 1, wherein the fistulais one of a carotid-cavernous fistula, a coronary fistula, an atrialseptal defect, and a ventricular septal defect.
 5. The method of claim1, wherein the second bulb has a fourth braid angle and the third bulbhas a fifth braid angle, the third braid angle less than the fourthbraid angle and the fifth braid angle.
 6. The method of claim 1, whereinthe second neck has an outer diameter oversized between 10% and 25% to awidth of the fistula and wherein the second neck has a length oversizedbetween 10% and 25% to a length of the fistula.
 7. The method of claim1, further comprising: inserting the guide catheter and a dilator intoan entry point in the vasculature, the dilator having a distal end;inserting a steerable guidewire into the guide catheter and the dilator,the steerable guidewire extending distal to the distal end of thedilator; advancing and steering the steerable guidewire; after advancingand steering the steerable guidewire, advancing the guide catheter anddilator over the steerable guidewire; after advancing the guide catheterand dilator over the steerable guidewire, removing the dilator; afterremoving the dilator, further advancing and steering the steerableguidewire to the first point in the vasculature; after further advancingand steering the steerable guidewire, advancing the guide catheter overthe steerable guidewire to the first point in the vasculature; and afteradvancing the guide catheter over the steerable guidewire to the firstpoint in the vasculature, removing the steerable guidewire.
 8. A methodof disrupting flow through a fistula, the method comprising: deploying aflow disruptor across the fistula through a microcatheter at a point invasculature proximate to the fistula, wherein deploying the flowdisruptor comprises: expanding a first plurality of bulbs on a firstside of the fistula, expanding a second plurality of bulbs on a secondside of the fistula, the second side of the fistula longitudinallyopposite the first side of the fistula, and extending a neck through thefistula, the neck between the first plurality of bulbs and the secondplurality of bulbs.
 9. The method of claim 8, wherein the firstplurality of bulbs comprises a first bulb having a first braid angle,the second plurality of bulbs comprises a second bulb having a secondbraid angle, and the neck has a third braid angle less than the firstbraid angle and the second braid angle.
 10. The method of claim 9,wherein the first plurality of bulbs comprises a third bulb having afourth braid angle, the second plurality of bulbs comprises a fourthbulb having a fifth braid angle, and wherein the third braid angle isless than the fourth braid angle and the fifth braid angle.
 11. Themethod of claim 8, wherein the first plurality of bulbs comprises: aproximal-most bulb having a first diameter, and a third bulb having asecond diameter less than the first diameter, and wherein the secondplurality of bulbs comprises: a distal-most bulb having a thirddiameter, and a fourth bulb having a fourth diameter less than the thirddiameter.
 12. The method of claim 8, wherein the flow disruptor has alongitudinal axis, wherein the flow disruptor comprises a second neckproximal to the first plurality of bulbs, wherein the flow disruptorcomprises a third neck distal to the second plurality of bulbs, andwherein the second neck and the third neck are radially offset from thelongitudinal axis.
 13. The method of claim 12, wherein the second neckand the third neck are differently radially offset from the longitudinalaxis.
 14. The method of claim 8, wherein the neck has an outer diameteroversized between 10% and 25% to a width of the fistula and wherein theneck has a length oversized between 10% and 25% to a length of thefistula.
 15. The method of claim 8, wherein the point in the vasculatureis a cavernous sinus.
 16. A method of disrupting flow through a fistula,the method comprising: deploying a flow disruptor across the fistulathrough a microcatheter at a point in vasculature proximate to thefistula, wherein deploying the flow disruptor comprises: expanding afirst bulb on a first side of the fistula, the first bulb having a firstbraid angle, and expanding a second bulb on a second side of thefistula, the second bulb having a second braid angle, the flow disruptorcomprising a neck between the first bulb and the second bulb, the necktraversing the fistula, the neck having a third braid angle less thanthe first braid angle and the second braid angle.
 17. The method ofclaim 16, wherein deploying the flow disruptor further comprises:expanding a third bulb on the first side of the fistula; and expanding afourth bulb on the second side of the fistula, wherein the first bulbhas a first diameter, the second bulb has a second diameter, the thirdbulb has a third diameter less than the first diameter, and the fourthbulb has a fourth diameter less than the third diameter.
 18. The methodof claim 16, wherein the flow disruptor has a longitudinal axis, whereinthe flow disruptor comprises a second neck proximal to the first bulb,wherein the flow disruptor comprises a third neck distal to the secondbulb, and wherein the second neck and the third neck are radially offsetfrom the longitudinal axis.
 19. The method of claim 18, wherein thesecond neck and the third neck are differently radially offset from thelongitudinal axis.
 20. The method of claim 16, wherein the second neckhas an outer diameter oversized between 10% and 25% to a width of thefistula and wherein the second neck has a length oversized between 10%and 25% to a length of the fistula.